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The latest on how medical technology is changing lives for the better

SmartBrief
Phase-in of DMEPOS fees should be delayed, AdvaMed, stakeholders tell Congress
Congressional leaders received a letter this week from nine national organizations, including AdvaMed, and 24 state ...Learn More
For more:
Read AdvaMed's news release supporting the Patient Access to Durable Medical Equipment ...Learn More
Financing round pulls in $51.2M for TransMedics
A round of equity funding has brought in $51.2 million for Andover, Mass.-based TransMedics. ...Learn More
Offering could bring in $6M for Great Basin Scientific
A public offering of 3.16 million units of common stock and warrants has been priced by Salt Lake City-based Great Basin ...Learn More
Life sciences startups secure $750K loans from Mass. agency
The Massachusetts Life Sciences Center has given orthopedic device maker MX Orthopedics and diagnostic product developer ...Learn More
Report predicts growth for global hip, knee orthopedic surgical implants market
A Medical Market Research report predicts the worldwide market for hip and knee orthopedic surgical implants will hit $34.57 ...Learn More
Study shows positive results for Endologix's endovascular system
A prospective, single-arm study that included 150 patients at 30 US and European sites showed positive results for ...Learn More
Experimental devices could allow in situ cancer cell analysis
An endoscope and a 3D imaging device, both based on multiphoton excited fluorescence microscopy, may accelerate diagnosis ...Learn More
Cell sorting system unveiled by Becton Dickinson
The FACSMelody system has been introduced by Becton Dickinson as an addition to its portfolio of cell sorters. ...Learn More
Drug-delivering implant to treat opioid addiction approved by FDA
The FDA on Thursday granted Braeburn Pharmaceuticals and Titan Pharmaceuticals approval for Probuphine, a first-of-its-kind, ...Learn More
EU expands approval for esophageal cooling device
European regulators have given Chicago-based Advanced Cooling Therapy expanded CE mark approval extending the use of its ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
SmartBrief will not publish Monday
In observance of Memorial Day in the US, SmartBrief will not publish Monday. Publication will resume ...Learn More
It's the curiosity that drives me. It's making a difference in the world that prevents me from ever giving up.
Deborah Meier, ...Learn More
Medtronic, Qualcomm Life partner to develop next-gen glucose monitors
Medtronic announced Wednesday that it is teaming up with Qualcomm Life, a subsidiary of digital communications company ...Learn More
Canada-based Alere unit launches $8.1M expansion project
Epocal, an Alere subsidiary that manufactures wireless-enabled blood diagnostic platforms, has announced an $8.1 million ...Learn More
Funding round pulls in $1.5M for CardioNXT
A round of equity funding has brought in $1.5 million for Westminster, Colo.-based medtech company CardioNXT. ...Learn More
Senseonics, Roche reach distribution deal on glucose monitor
A deal has been reached between Senseonics and Roche Holding to allow the latter to exclusively distribute Senseonics' ...Learn More
Asia-Pacific distribution negotiation for surgical system extended by Titan Medical
Titan Medical said its negotiations with Longtai Medical to exclusively distribute Titan's Sport Surgical System in the ...Learn More
Tiny animal-tissue robot could be used for GI procedures
Massachusetts Institute of Technology researchers have developed a concept for a tiny robot that could be swallowed, unfold ...Learn More
Neurostimulator from Mainstay Medical wins EU approval
European regulators have given Dublin-based Mainstay Medical CE mark approval for its ReActiv8 neurostimulator, a device ...Learn More
FDA, EU clear hybrid fixation implant from Implanet
The FDA has given Implanet clearance for the Jazz Claw, a hybrid implant indicated for treating adults with complex ...Learn More
Australia OKs diagnostic instrument from Illumina
The Australian Therapeutic Goods Administration has cleared the MiSeqDx instrument from Illumina for clinical use. ...Learn More
Cytomegalovirus test approved for use in stem cell transplant recipients
Roche Holding's in vitro diagnostic assay for cytomegalovirus has been approved by the FDA for use in patients who receive ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Striving for success without hard work is like trying to harvest where you haven't planted.
David Bly, ...Learn More
IPO could bring in $13M for Viveve
An initial public offering of almost 1.6 million shares has been priced by Sunnyvale, Calif.-based Viveve in hopes of ...Learn More
Funding round pulls in $12M for Zebra Medical Vision
A round of funding has brought in $12 million for Zebra Medical Vision, an Israel-based startup that develops big-data ...Learn More
U. of Pittsburgh taps InCube Labs for $10M DOD subcontract
The University of Pittsburgh has awarded San Antonio-based InCube Labs a $10 million subcontract to help develop an ...Learn More
Financing round brings in $5.2M for BrightWater Medical
A round of Series A financing has brought in $5.2 million for Mountain View, Calif.-based ureteral medical device maker ...Learn More
Propeller Health to develop inhaler sensor with Vectura
Madison, Wis.-based Propeller Health has signed a partnership with UK-based Vectura Group to create an add-on sensor that ...Learn More
New corporate secretary, CFO named by Entellus Medical
Brent Moen, who has over 25 years of experience in finance, has been tapped to serve as corporate secretary and chief ...Learn More
Study shows positive results for Covidien's stent retriever
A study in the journal Radiology showed positive results for the Solitaire device, a stent retriever developed by Covidien, ...Learn More
Cardiac pacing device monitor from Biotronik debuts in US
The CardioMessenger Smart, a portable monitoring device that allows for remote connectivity of insertable cardiac monitors, ...Learn More
FDA panel backs St. Jude Medical's cardiac implant
An FDA panel has voted in favor of approving St. ...Learn More
Interbody fusion device from Interventional Spine cleared by FDA
The FDA has given Interventional Spine clearance for its 8-degree Lumbar Lordotic Opticage Expandable Intervertebral Body ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
If you're not reaching back to help anyone, then you're not building a legacy.
Germany Kent, media ...Learn More
Luminex raises bid for Nanosphere to about $77M
Luminex has increased its bid to acquire Nanosphere from $1.35 per share to $1.70 per share, raising the deal's value from ...Learn More
Offering of Wright Medical shares could pull in $120M
A secondary offering of 6.2 million shares has been announced by Wright Medical in hopes of raising up to $120 million. ...Learn More
Varian Medical's imaging component unit to be spun off this year
Varian Medical on Monday announced plans to split off its imaging components business into a standalone public entity using ...Learn More
Offering could pull in $500M for Quest Diagnostics
Quest Diagnostics has unveiled a plan to raise $500 million in a public offering of senior notes. ...Learn More
Global health care wearable devices market to reach $18.9B in 2020
A Frost & Sullivan analysis predicts the global market for health care wearable devices will reach $18.9 billion in 2020, at ...Learn More
ENDRA teams up with GE Healthcare to develop ultrasound technology
GE Healthcare and ENDRA Life Sciences are forming a partnership to develop the latter's Thermo Acoustic Enhanced UltraSound ...Learn More
Data show positive results for Baxter's dialyser
Data from abstracts presented at the European Renal Association and European Dialysis and Transplant Association's 53rd ...Learn More
Bone autograft extender unveiled by NuVasive
AttraX putty has been introduced in the US by San Diego-based NuVasive as an addition to its biologics portfolio. ...Learn More
Reusable colonoscopy device from Avantis cleared by FDA
Avantis Medical Systems has obtained clearance from the FDA for its Third Eye Panoramic as a reusable device for ...Learn More
FDA clears single-use endoscope valves from EndoChoice
The FDA has given Alpharetta, Ga.-based EndoChoice 510(k) clearance for its sterile, disposable air/water and suction valves ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
Life is bristling with thorns, and I know no other remedy than to cultivate one's garden.
Voltaire, writer and ...Learn More
J&J robot-assisted surgery unit to move into product design
Johnson & Johnson officials told investors last week that the company's robot-assisted surgery unit, Verb Surgical, will ...Learn More
Offering could pull in $5M for Cancer Genetics
A direct offering of common stock and warrants could bring in $5 million for Rutherford, N.J.-based diagnostics company ...Learn More
Empire Genomics gets $1.75M boost
A round of follow-on financing led by investor BroadOak Capital Partners has brought in $1.75 million for Buffalo, ...Learn More
Mass. agency to support life sciences projects through capital program
A capital program with up to $35 million in funding will be launched this month by the Massachusetts Life Sciences Center ...Learn More
NovoCure names executive chairman
William Doyle will become the executive chairman of NovoCure under a deal signed with the company earlier this month. ...Learn More
First US procedure using meniscus implant recorded by Active Implants
A patient at Salt Lake Regional Medical Center in Utah was the first in the US to undergo meniscus replacement using Active ...Learn More
Gastrointestinal aspiration needle unveiled by Olympus
The EZ Shot 3 Plus needle has been introduced by Olympus as an addition to its gastrointestinal portfolio. ...Learn More
EU OKs drug-eluting balloon from iVascular
European regulators have given Spanish coronary and endovascular device maker iVascular CE mark approval for its Luminor 18 ...Learn More
Roche's in vitro test wins approval from FDA
Roche Holding has obtained approval from the FDA for its Ventana PD-L1 assay, which assesses PD-L1 status in patients with ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
One of the greatest regrets in life is being what others would want you to be, rather than being yourself.
Shannon Alder, ...Learn More
Royal Philips, S.C. health care provider reach $36M long-term deal
An eight-year partnership valued at $36 million has been signed by Royal Philips and Medical University of South Carolina ...Learn More
J&J, HP unit team up, aim to improve health care outcomes through 3D printing
Johnson & Johnson has partnered with an HP unit in an effort to improve health care outcomes at lower costs by using ...Learn More
Funding round pulls in $1.7M for Bone Solutions
A private placement has brought in $1.7 million for Dallas-based Bone Solutions, weeks before it intends to launch its ...Learn More
Report predicts growth for worldwide medical imaging market
An Allied Market Research report predicts the global medical imaging market will see a compound annual growth rate of 5% ...Learn More
New CEO, president named by Flowonix Medical
Larry Heaton, former CEO, president and director of Cardiox, has been tapped to serve as CEO and president of Flowonix ...Learn More
Registry completed to test NinePoint Medical's endomicroscopy system
The primary phase of a registry investigating the use of NinePoint Medical's NvisionVLE Imaging System in high-resolution ...Learn More
First surgery using robotic spinal surgery system in Spain recorded by Medtech
A patient with degenerative disc disease at La Fe Hospital of Valencia was the first in Spain to undergo a spine surgery ...Learn More
Platform for cervical spine fusions launched by Medtronic
Spine Essentials, a kit of implants and instruments designed for streamlining one- and two-level cervical spine fusion ...Learn More
Patient-controlled infusion system debuted by Hospira
The LifeCare PCA 7.0 Infusion System has been introduced by Pfizer subsidiary Hospira for improving pain management ...Learn More
Boston Scientific wins FDA approval for spinal cord stimulator
The FDA has granted Boston Scientific approval for its Precision Montage MRI-safe spinal cord stimulator system, which ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Unless you try to do something beyond what you have already mastered, you will never grow.
Ronald Osborn, teacher and ...Learn More
Medtronic announces deals with Smith & Nephew, Mazor Robotics
Medtronic has reached a $350 million agreement with Smith & Nephew to acquire the latter's gynecology unit that offers ...Learn More
Offering brings in $400M for Teleflex
Wayne, Pa.-based Teleflex has raised $400 million, before underwriting commissions and discounts, from an offering of senior ...Learn More
Pulse Biosciences obtains $20M from offering
An initial public offering of 5 million shares has pulled in $20 million for Pulse Biosciences. ...Learn More
Funding round pulls in $4.5M for Decisio Health
A round of Series B funding led by DECLATEX has brought in $4.5 million for Decisio Health. ...Learn More
Report predicts growth for global diagnostic imaging market
A P&S Market Research report predicts the worldwide diagnostic imaging market will see a compound annual growth rate of 5% ...Learn More
New president, CEO named by EndoStim
Rohan Hoare, former president of Salient Medical, has been tapped to serve as president and CEO of St. Louis-based EndoStim. ...Learn More
Lung perfusion device studied in US
The XPS device developed by Sweden's XVIVO Perfusion is being studied for the conditioning of donor lungs in clinical trials ...Learn More
St. Jude Medical launches fractional flow reserve system in Europe
The PressureWire X Guidewire fractional flow reserve measurement system is being launched by St. ...Learn More
CMS begins coverage analysis for leadless pacemakers
The CMS has released a memo initiating an analysis of whether it should provide national coverage for leadless pacemakers. ...Learn More
Siemens' tomosynthesis platform wins FDA approval for 3D-only breast screening
The FDA has given Siemens Healthineers approval to use its Mammomat Inspiration with Tomosynthesis Option as a standalone, ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
Diligence is the mother of good fortune.
Miguel de Cervantes, ...Learn More
German diagnostics firm sold to Siemens Healthineers
NEO New Oncology, a cancer diagnostics firm based in Germany, has been acquired by Siemens Healthineers for undisclosed ...Learn More
Singulex gets $50M boost from Grifols
Singulex, a developer of clinical diagnostic technologies, has received a $50 million investment from Grifols, which gives ...Learn More
Funding round brings in $40M for Mitralign
A round of Series E financing has brought in almost $40 million for Tewksbury, Mass.-based Mitralign. ...Learn More
Royal Philips, Profound team up to market ultrasound ablation system
Royal Philips and Profound Medical have expanded their existing collaboration through a deal to commercialize the latter's ...Learn More
11 medtech startups chosen to join Fla. accelerator program
GuideWell and Healthbox have named 11 early-stage medtech firms that will take part in a Florida–based accelerator ...Learn More
Report predicts growth for global portable ultrasound market
A P&S Market Research report predicts the worldwide market for portable ultrasound devices will see a compound annual growth ...Learn More
Studies show positive results for Brainsway's magnetic brain stimulation device
Studies presented at the American Psychiatric Association 2016 Annual Meeting showed positive results for Brainsway's Deep ...Learn More
CardioFocus to launch laser ablation catheter in select US markets
The HeartLight laser ablation catheter is expected to be released by CardioFocus on a limited basis in the US by July. ...Learn More
FDA clears osteoporosis diagnostics device from Bone Index
The FDA has given Finland-based Bone Index 510(k) clearance for its point-of-care device called Bindex. ...Learn More
FDA clears bone fixation device from First Ray
Surgical Frontiers startup First Ray has obtained 510(k) clearance from the FDA for its CortiClamp System. ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
The man who moves a mountain begins by carrying away small stones.
Confucius, philosopher and ...Learn More
Luminex signs deal to buy Nanosphere
Luminex agreed to pay $58 million plus $25 million in debt to acquire Nanosphere, an Illinois-based firm that produces ...Learn More
Funding round pulls in $30M for Impulse Dynamics
A round of funding has brought in $30 million for German medtech firm Impulse Dynamics. ...Learn More
Deal to buy Cayenne Medical finalized by Zimmer Biomet
The acquisition of Arizona-based Cayenne Medical, a maker of soft tissue repair and reconstruction solutions for the ...Learn More
ReCor, Otsuka enter deal to market renal denervation device in Asia
Japan-based conglomerate Otsuka Pharmaceutical has made a deal to exclusively conduct trials, seek regulatory approval and ...Learn More
Delphinus moves its headquarters in Mich.
The corporate headquarters for Delphinus Medical Technologies, a developer of tomographic ultrasound, are being moved from ...Learn More
First human implanted with micro-anchor heart device recorded by BioVentrix
A patient at Vilnius University Hospital in Lithuania was the first human to be implanted with the Revivent device from San ...Learn More
Stented tissue heart valve introduced by St. Jude Medical
The Trifecta GT stented tissue valve has been released by St. ...Learn More
AdvaMed raises concerns about India's medical device regulation
Although the implementation of the SUGAM governance system has enabled online filing, tracking and approval of applications, ...Learn More
FDA clears EndoGastric Solutions' gastroesophageal barrier device
EndoGastric Solutions has obtained 510(k) clearance from the FDA for its EsophyX Z device, which is intended for providing ...Learn More
Interbody spacer system from Orthofix cleared by FDA
Orthofix has received clearance from the FDA for its FORZA PEEK Titanium Composite Spacer System. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
It is not enough that we do our best; sometimes we must do what is required.
Winston Churchill, former British prime ...Learn More
Wright Medical gets $395M boost
A private placement of convertible senior notes involving a syndicate of investors has brought in $395 million for Wright ...Learn More
Deal to acquire VirtualScopics finalized by BioTelemetry
The acquisition of clinical trial imaging firm VirtualScopics, valued at $15.5 million, has been completed by BioTelemetry, ...Learn More
Waters obtains $250M from private placement
A private placement of senior notes worth $250 million has been completed by Waters, according to a filing with the SEC. ...Learn More
Funding round brings in $12M for ExThera Medical
A round of Series A financing has pulled in $12 million for Martinez, Calif.-based ExThera Medical, with $491,018 remaining ...Learn More
Public offering could pull in $11M for Sensus Healthcare
An initial public offering of 1.8 million units of common shares and warrants has been refiled by Boca Raton, Fla.-based ...Learn More
Initial cases using interbody system recorded by Life Spine
Initial surgical procedures using the PROLIFT Expandable Interbody System have been completed by Huntley, Ill.-based Life ...Learn More
SI-BONE partners with Yale University to share clinical trial results
SI-BONE has agreed to share clinical trial data with the Yale University Open Data Access Project, whose mission is to ...Learn More
Final guidance on postmarket device surveillance released by FDA
The FDA has issued final guidance to help medical device manufacturers comply with postmarket surveillance orders for ...Learn More
FDA issues draft guidance on infectious disease NGS Dx devices
Draft guidance has been released by the FDA to provide recommendations on designing validation studies for next-generation ...Learn More
New indication for Xtant Medical's spinal fixation system cleared by FDA
The FDA has given Xtant Medical clearance to a add posterior cervical screw indication for its Certex Spinal Fixation ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Mistakes are the growing pains of wisdom.
William George Jordan, writer and ...Learn More
Offering could bring in $400M for Teleflex
An offering of senior notes has been priced by Wayne, Pa.-based Teleflex in hopes of obtaining $400 million. ...Learn More
EndoStim obtains $25M from financing round
A round of Series D financing led by Switzerland-based investor Endeavour Vision has brought in $25 million for St. ...Learn More
Private placement could pull in $10.4M for OpGen
A private placement of common stock and warrants that could raise $10.4 million has been announced by Gaithersburg, ...Learn More
Amarantus, Theranostics acquisitions finalized by Avant
The acquisitions of Amarantus Diagnostics and Theranostics Health have been completed by Scottsdale, Ariz.-based Avant ...Learn More
Cardinal Health enters deal to market stents from Biosensors
Cardinal Health has agreed to allow Cordis, its interventional vascular business, to distribute Biosensors' coronary stent ...Learn More
Median Technologies to unveil Mass. facility next week
Median Technologies, a France-based medical imaging software company, will open a facility in Woburn, Mass., on May 16. ...Learn More
Study shows positive results for Boston Scientific's heart device
A 150-patient, four-site study in the Journal of the American College of Cardiology showed positive results for Boston ...Learn More
Uterine tissue removal system unveiled by Hologic
The MyoSure REACH, a system intended for preventing abnormal uterine bleeding through the removal of polyps and fibroids, ...Learn More
EU OKs atrial decompression device from Corvia Medical
European regulators have given Corvia Medical approval for its InterAtrial Shunt Device, which is intended for treating ...Learn More
Camber's anterior interbody fusion system cleared by FDA
The FDA has granted Camber Spine Technologies 510(k) clearance for its ENZA Zero Profile Anterior Interbody Fusion system, ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
The only way you are going to have success is to have lots of failures first.
Sergey Brin, computer scientist and ...Learn More
Funding round pulls in $8M for NeuSpera Medical
A round of equity financing involving three anonymous investors has brought in $8 million for Santa Clara, Calif.-based ...Learn More
J&J life sciences incubator launches in Toronto
Johnson & Johnson Innovation has launched its sixth JLABS facility, which is located in Toronto and has 22 participating ...Learn More
BioDiscovery to provide software for Illumina's NGS assay
Illumina has entered into a deal with BioDiscovery to use the latter's NxClinical data visualization software as a tool for ...Learn More
Report: Global neurology devices market poised for growth
A Grand View Research report predicts the worldwide market for neurology devices will hit $10.8 billion by 2022. ...Learn More
New CFO, chief compliance officer named by GI Dynamics
Jim Murphy, former chief financial officer at Oxigene and HemaSure, has been chosen to serve as chief financial officer of ...Learn More
First surgeries using spine surgical range recorded by Safe Orthopaedics
Patients in France and Switzerland were the first to undergo surgeries using the SteriSpineCC range from Safe Orthopaedics. ...Learn More
Real-time feature of NinePoint's imaging system cleared by FDA
NinePoint Medical has obtained 510(k) clearance from the FDA to market the real-time targeting feature of its NvisionVLE ...Learn More
Trunzo: Breakthrough medtech bill would strengthen patient access to treatments
A bill establishing a priority review process for breakthrough medical technologies has gained wide bipartisan support in ...Learn More
Right to Try bill introduced in Senate
Legislation that would enable terminally ill patients to gain access to experimental treatments or devices that are still ...Learn More
Lungpacer's diaphragm pacing system wins expedited access status from FDA
The FDA has given Lungpacer Medical, a maker of neurostimulation systems for diaphragm muscle complications, Expedited ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
The only strategy that is guaranteed to fail is not taking risks.
Mark Zuckerberg, ...Learn More
Senate committee issues report on physician-owned distributorships
A report was released by the Senate Finance Committee recommending stricter transparency laws and hospital policies to ...Learn More
For more:
Read the news release in which AdvaMed applauds the Senate Finance Committee for its report on physician-owned ...Learn More
BioMedical Enterprises sold to DePuy unit
BioMedical Enterprises, a maker of nitinol orthopedic implants for treating deformities of the foot, ankle, hand and wrist, ...Learn More
BioTelemetry completes tender offer for VirtualScopics shares
A tender offer for all outstanding common and preferred shares of VirtualScopics, a clinical trial imaging company, was ...Learn More
GE, Heritage Valley reach imaging managed equipment service deal
A 14-year deal has been reached by GE Healthcare to bring MRI and CT scanners, as well as ultrasound equipment, to Heritage ...Learn More
Roche expects diabetes-testing business to grow
Roche Holding expects to see its diabetes-testing business rebound in 2017 and has no plans to sell off the unit despite ...Learn More
Studies show positive results for NeoTract's enlarged prostate treatment
Two studies presented at the annual American Urological Association meeting in San Diego showed positive results for ...Learn More
Spinal surgery device to be unveiled by SpineGuard
The PediGuard Threaded device is expected to be launched next week by Paris-based SpineGuard at the SpineWeek 2016 ...Learn More
Commentary: Medical device tax suspension promotes N.Y. medtech innovation
The medical technology industry in New York continues to save and improve the lives of people around the world through ...Learn More
EU OKs continuous glucose monitor from Senseonics
European regulators have given Senseonics CE mark approval for its Eversense continuous glucose monitoring system. ...Learn More
South Korea OKs sequencing instruments from Illumina
South Korea's Ministry of Food and Drug Safety has approved Illumina's MiSeqDx instrument and MiSeqDx Universal kit for ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
You live but once; you might as well be amusing.
Coco Chanel, fashion ...Learn More
DOD taps Masimo for $36M pulse oximeters contract
The Department of Defense has awarded Masimo a five-year contract valued at almost $36 million to provide the Army, Marine ...Learn More
Siemens creates MR fingerprinting partnership with Case Western
Siemens Healthineers and Case Western Reserve University are teaming up to explore magnetic resonance fingerprinting, a ...Learn More
Greatbatch, WiTricity expand partnership on wireless energy transfer technology
A licensing and collaboration agreement between Greatbatch and Watertown, Mass.-based WiTricity has been expanded to apply ...Learn More
Global ultrasound market poised for growth, research firm says
P&S Market Research predicts the worldwide ultrasound market will see a compound annual growth rate of 5.5% through 2022. ...Learn More
Aetna covers breast cancer test from NanoString
NanoString Technologies has received a positive coverage decision from Aetna for Prosigna, a test for evaluating the ...Learn More
New CEO, board member named by Personal Genome Diagnostics
Douglas Ward has been chosen to serve as CEO and a member of the board of directors at Baltimore-based Personal Genome ...Learn More
Study shows positive results for Boston Scientific's S-ICD system
A 994-patient, 42-site study presented at the Heart Rhythm Society's scientific sessions in San Francisco showed positive ...Learn More
Sacroiliac joint fusion system unveiled by CoreLink
The Entasis Sacroiliac Joint Fusion System has been introduced by CoreLink, a US maker of spinal implants. ...Learn More
3D printing guidance for medical devices released by FDA
Draft guidance has been published by the FDA to provide medical device makers with initial thoughts on technological ...Learn More
EU OKs collagen corneal shields from Oasis Medical
European regulators have given Glendora, Calif.-based Oasis Medical CE mark approval for its Soft Shield collagen corneal ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Correction
A headline in Monday's brief provided the wrong name for the company acquiring Galil Medical. ...Learn More
If you want to gather honey, don't kick over the beehive.
Dale Carnegie, writer and ...Learn More
TG to buy Galil Medical in up-to-$110M deal
London-based health care firm BTG has entered a deal to acquire Arden Hills, Minn.-based Galil Medical, a maker of ...Learn More
Funding round pulls in $75M for Intarcia Therapeutics
A round of debt financing from MidCap Financial and Silicon Valley Bank has brought in $75 million for Boston-based Intarcia ...Learn More
Seed financing round brings in $1.5M for MIODx
A round of seed financing has pulled in $1.5 million for MIODx. ...Learn More
Pain diagnostics company acquired by Proove Biosciences
Algynomics, a research-stage diagnostics company focused on chronic pain, has been acquired by Proove Biosciences for ...Learn More
Olympus tapped to distribute colonoscopy device in US, Canada
A deal between Olympus and Netherlands-based Norgine and its unit Arc Medical Design to distribute the Endocuff Vision in ...Learn More
Report predicts growth for global orthopedic devices market
A Transparency Market Research report predicts the worldwide market for orthopedic devices will hit $41.2 billion by the end ...Learn More
Study shows positive results for Osprey Medical's contrast modulation device
A 578-patient, 39-site study presented at the Society for Cardiovascular Angiography and Interventions scientific sessions ...Learn More
FDA clears Mobius Medical's 3D quality assurance software
The FDA has granted Mobius Medical clearance for its Mobius3D software. ...Learn More
Urologic ultrasound from Signostics cleared by FDA
The FDA has given Signostics clearance for its Uscan ultrasound visualization device, which provides highly accurate imaging ...Learn More
Australia OKs hepatitis C genotyping assay from Vela
Australian regulators have given Singapore-based Vela Diagnostics approval for the diagnostic use of its next-generation ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
When we fail, our pride supports us; when we succeed, it betrays us.
Charles Caleb Colton, cleric and ...Learn More
Baxter raises exchange offer for Baxalta shares
Baxter has announced an offer to exchange its own shares for nearly 13.4 million shares of its remaining stake in Baxalta, ...Learn More
Share buyback program initiated by Cardinal Health
Dublin, Ohio-based Cardinal Health said it will buy back up to $1 billion in common shares in addition to the $393 million ...Learn More
SonaCare, Royal Philips unit reach licensing deal
Invivo, a Royal Philips unit, and SonaCare Medical have reached a licensing deal to allow Invivo's UroNav fusion software to ...Learn More
New CEO named by SafeOp Surgical
Gene Cattarina has been tapped to serve as CEO of Hunt Valley, Md.-based SafeOp Surgical. ...Learn More
Q2 revenue rises for Becton Dickinson
Becton Dickinson generated $3.07 billion in revenue during its fiscal second quarter ending March 31, up from $2.05 billion ...Learn More
Leadless pacemaker under development at Boston Scientific
Boston Scientific is developing its own leadless pacemaker called Empower, which is designed to work with the company's ...Learn More
Mazor Robotics reports installation of spine surgery guidance system in Miami
Mazor Robotics' Renaissance Guidance System has been installed at Mercy Hospital in Miami for use in spine surgery. ...Learn More
Researchers develop microwave device for monitoring blood glucose
Researchers at Cardiff University's School of Engineering have developed a portable, noninvasive device that uses low-level ...Learn More
SentreHEART's suture delivery device cleared by FDA
The FDA has given SentreHEART 510(k) clearance for its LARIAT XT. ...Learn More
FDA OKs expanded use for Crospon's endolumenal imaging system
The EndoFLIP endolumenal imaging system from Ireland-based Crospon has been cleared by the FDA for an additional indication. ...Learn More
Avoiding and Managing FDA Compliance Problems webinar
May 9 | 1:00 p.m.-2:00 p.m. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Rivers know this: There is no hurry. We shall get there someday.
A.A. Milne, ...Learn More
Public offering pulls in $25M for Valeritas
An "alternative public offering" consisting of a reverse merger and a private placement has brought in $25 million for ...Learn More
CorMatrix sells programs to Ligand Pharmaceuticals
The rights to CorMatrix's products indicated for vascular, cardiac and pericardial tissue repair, as well as its CanGaroo ...Learn More
Medtronic selected as UnitedHealth's preferred insulin pump provider
Medtronic has been chosen by UnitedHealth Group as its preferred provider of insulin pumps. ...Learn More
Siemens announces new name for health care unit
Siemens Healthcare has been rebranded by its parent company Siemens and will now be known as Siemens Healthineers to reflect ...Learn More
New executive VP, CFO named by Medtronic
Karen Parkhill, former vice chairman and chief financial officer at Comerica, has been tapped to serve as executive vice ...Learn More
First US surgery using robotic spinal surgery device recorded by Medtech
A patient at Miami Valley Hospital in Dayton, Ohio, was the first in the US to undergo a spine surgery using the ROSA Spine ...Learn More
Fluid management device unveiled by Fresenius Renal Therapies
The CLiC device has been launched by Fresenius Renal Therapies for fluid management in patients who have end-stage renal ...Learn More
Ablation catheters from Boston Scientific get FDA approval
The FDA has granted Boston Scientific premarket approval for its IntellaNav XP and IntellaNav MiFi XP mapping and ablation ...Learn More
EU OKs 3D cardiac mapping system from Acutus Medical
European regulators have given Carlsbad, Calif.-based Acutus Medical CE mark approval for its AcQMap high-resolution imaging ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Achieving success is a challenge, but so is struggling, so you may as well choose success.
Rob Liano, writer and ...Learn More
Investment firm secures $233M for health care fund
MVM Life Science Partners has raised $233 million for MVM IV, its fourth fund, dedicated to US- and Europe-based companies ...Learn More
Ill. private equity firm to buy Symmetry Surgical in $140M deal
RoundTable Healthcare Partners, an Illinois-based private equity firm, will acquire Antioch, Tenn.-based Symmetry Surgical ...Learn More
Funding round stretched by Helius Medical to $8.1M
An additional 1.1 million units have been sold by Helius Medical Technologies from an overallotment option on its recent ...Learn More
EnteroMedics gets $6.3M funding boost
The third tranche of an offering of senior amortizing convertible notes has pulled in $6.3 million for St. ...Learn More
Dexcom reaches deal to buy distributor
Dexcom, a diabetes management device maker, has agreed to acquire its distributor Nintamed, which has locations in Germany, ...Learn More
BioNovus, Kan. institute form partnership, aim to advance medical innovations
A partnership was announced between BioNovus Innovations and the University of Kansas Medical Center's Institute for ...Learn More
Study shows positive results for Medtronic's 2-level cervical disc
A 397-patient study presented at the 84th-annual Meeting of the American Association of Neurological Surgeons in Chicago ...Learn More
Spineology's pedicular fixation system debuts in US
The Palisade Pedicular Fixation System has been introduced in the US by Spineology. ...Learn More
Biotronik's cardiac resynchronization defibrillator gets FDA approval
The FDA has given Biotronik approval for its Iperia ProMRI HF-T cardiac resynchronization defibrillator, a device intended ...Learn More
FDA clears bone fixation device from Surgical Frontiers startup
Surgical Frontiers startup First Ray has obtained clearance from the FDA for its Stealth Staple system, an intraosseous ...Learn More
Avoiding and Managing FDA Compliance Problems webinar
May 9 | 1:00 p.m.-2:00 p.m. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Change means that what was before wasn't perfect. People want things to be better.
Esther Dyson, ...Learn More
Sinocare to buy Indianapolis device maker for $200M
Sinocare, a manufacturer of blood glucose monitoring systems based in China, has agreed to pay up to $200 million in cash to ...Learn More
Private equity firm acquires majority ownership of Amendia
Private equity firm Kohlberg & Co. has acquired majority ownership of Marietta, Ga.-based Amendia. ...Learn More
B. Braun, NuMED extend distribution deal to include aortic coarctation stent
B. Braun Interventional Systems has added the Cheatham Platinum stent to its exclusive U.S. ...Learn More
Accuray enters systems integration deal with medPhoton
Accuray has teamed up with medPhoton GmbH to integrate the latter's ImagingRing volumetric image guidance system into ...Learn More
Report: Global ultrasound devices market poised for growth
A Grand View Research report predicts the worldwide market for ultrasound devices will hit $11.1 billion by 2024. ...Learn More
Senior VP for design, user experience named by Intuitive Surgical
Charles Jones has been tapped to serve as senior vice president of design and user experience at Intuitive Surgical. ...Learn More
Trial shows positive results for St. Jude Medical's heart device
A 50-patient, 10-site study presented at the International Society for Heart and Lung Transplantation 2016 Scientific ...Learn More
FDA clears informatics platform from Synaptive Medical
Synaptive Medical has secured clearance from the FDA for its ImageDrive Pro, an informatics platform designed for ...Learn More
MRI-compatible valves, shunts from Medtronic cleared by FDA
The FDA has given Medtronic clearance for its StrataMR valves and shunts, which are included in the company's Strata line of ...Learn More
Medtronic's implantable defibrillators win FDA OK
The FDA has granted Medtronic approval for its Visia AF MRI SureScan and AF implantable cardioverter defibrillators, which ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
We must walk consciously only part way toward our goal, and then leap in the dark to our success.
Henry David Thoreau, ...Learn More
UK medical device maker acquired by Stryker for $52M
SIW Holdings unit Stanmore Implants, a UK-based maker of limb salvage devices for patients with orthopedic cancers, has been ...Learn More
Abbott's offer to cancel merger deal turned down by Alere
Alere said last week it expected its $5.8 billion merger agreement with Abbott Laboratories to be finalized according to its ...Learn More
Offering could pull in $5M for Biocept
A public offering of common stock and warrants has been priced by Biocept in hopes of obtaining $5 million. ...Learn More
Funding round brings in $2.5M for Cardiac Insight
A round of Series C financing has pulled in $2.5 million for Cardiac Insight, a spinoff of the University of Washington. ...Learn More
Integra LifeSciences, AlloSource reach deal to market acellular matrices
Integra LifeSciences has obtained access and marketing rights to the HuMend acellular dermal matrix in an agreement with ...Learn More
Study: Sterilizing polymer implants may be more viable with ozone gas
Ozone gas may be used as a cheaper and more convenient option than existing methods to disinfect medical implants made of ...Learn More
Wenzel Spine starts full US release of interbody fusion system
Wenzel Spine has announced the full US commercial launch of its VariLift-LX, a zero-profile technology for use in minimally ...Learn More
Surgical burn protection system unveiled by Encision
The AEM EndoShield 2 Burn Protection System has been introduced by Boulder, Colo.-based Encision for use in laparoscopic ...Learn More
Intelligent Implant's 2-level fusion system cleared by FDA
Charlotte, N.C.-based Intelligent Implant Systems has obtained clearance from the FDA for its Revolution Spinal System for ...Learn More
Quest Diagnostics approval widens access to emergency Zika virus test
Quest Diagnostics has received emergency use authorization from the FDA for its molecular Zika virus test, which checks for ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
The future cannot be predicted, but futures can be invented.
Dennis Gabor, electrical engineer and ...Learn More
Abbott's Alere purchase to continue as planned amid St. Jude Medical buy
Abbott said Thursday that the completion of its previously announced $5.8 billion acquisition of Alere will not be affected ...Learn More
CEO looks to widen Illumina's offerings with tests
Francis deSouza, Illumina's new CEO, has unveiled a five-year plan aimed at expanding the company's offerings from ...Learn More
Dehaier, Liaison Interactive reach $20M securities purchase deal
Hangzhou Liaison Interactive Information Technology has reached a deal to acquire 11.11 million restricted common shares ...Learn More
Offering pulls in $5.3M for PAVmed
An initial public offering has brought in $5.3 million for PAVmed after it was extended last month for 45 days. ...Learn More
Synaptive Medical sells neurosurgical solution to Inova
The BrightMatter Surgical Solution from Toronto-based Synaptive Medical has been sold to Inova Fairfax Medical Campus and ...Learn More
Data show positive results for Medtronic's saphenous vein closure system
Data from a trial presented at the 2016 Charing Cross Symposium showed positive results for Medtronic's VenaSeal closure ...Learn More
Direct Flow modifies trial for heart valve system
Direct Flow Medical has announced modifications, based on recent FDA approvals, to a trial of its transcatheter aortic valve ...Learn More
5 surgical devices to be unveiled by NuVasive
Five surgical solutions are expected to be introduced by NuVasive at the 84th American Association of Neurological Surgeons ...Learn More
India extends free sale certificate validity for device exports
The Drug Controller General of India has notified state drug regulators that they may grant free sale certificates for the ...Learn More
Meridian's direct pneumonia test wins EU approval
European regulators have given Meridian Bioscience CE mark approval for its illumigene Mycoplasma Direct, a molecular ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Bad times have a scientific value. These are occasions a good learner would not miss.
Ralph Waldo Emerson, ...Learn More
St. Jude Medical to be acquired by Abbott for $25B
Abbott is offering $25 billion to buy St. ...Learn More
Q1 sales rise for Boston Scientific
Boston Scientific generated $1.96 billion in sales during the three months ending March 31, up 11% from the same period a ...Learn More
Q2 revenue increases for Hologic
Hologic generated $693.3 million in revenue during its fiscal second quarter ending March 26, up from $655.5 million in the ...Learn More
Accuray reports Q3 revenue growth
Accuray reported that its revenue rose 8% to $105.3 million during its fiscal third quarter ending March 31. ...Learn More
Titan Spine appoints vice president of general counsel
Ragan Cheney, a former in-house senior legal consultant at Associated Financial Group, has been tapped to serve as vice ...Learn More
EU patent issued to Colibri Heart Valve
Broomfield, Colo.-based Colibri Heart Valve has secured a patent from the European Patent Office for its method of creating ...Learn More
Study shows positive results for Medtronic's abdominal stent graft
A study of 1,200 patients at 79 sites presented at the 2016 Charing Cross Symposium in London showed positive results for ...Learn More
Communication platform for joint replacement surgery unveiled by Stryker
The JointCOACH digital patient engagement and education platform has been introduced by Stryker. ...Learn More
Patient-specific rod from Medicrea wins FDA approval
The FDA has given Medicrea approval for its patient-specific UNiD cervical rod, which is intended to be secured with the ...Learn More
FDA clears fluid management system from Potrero Medical
Potrero Medical has secured 510(k) clearance from the FDA for its Accuryn monitoring system, which is intended for use in ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
If you are not willing to risk the unusual, you will have to settle for the ordinary.
Jim Rohn, entrepreneur and motivational ...Learn More
Jacobs Institute, Stratasys to build center of excellence for medical 3D printing
Stratasys and the Jacobs Institute in Buffalo, N.Y., have teamed up to create a center of excellence for advancing 3D ...Learn More
Q1 transcatheter heart valve sales rise for Edwards Lifesciences
Edwards Lifesciences reported that its worldwide sales of transcatheter heart valves grew 37% to $367.8 million during the ...Learn More
Baxter reports Q1 profit growth
Baxter generated $3.38 billion in profits during the first quarter, up 684.6% from the same period in the previous year, due ...Learn More
Lexogen taps TATAA Biocenter to distribute NGS products in Europe
TATAA Biocenter has agreed to distribute Lexogen's next-generation sequencing products in Sweden, Denmark, Norway, Germany, ...Learn More
Olympus announces senior-level promotions
Donna Miller has been promoted to HQ legal head and global general counsel at Olympus, where she previously served as ...Learn More
Data shows positive results for Biotronik's cardioverter defibrillator leads
Data from 3,840 patients at 146 US sites showed positive results for Biotronik's Linoxsmart cardioverter defibrillator ...Learn More
Chinese patent issued to Pinnacle Spine for spinal fusion technology
Dallas-based Pinnacle Spine Group has obtained its first international patent for its InFill fusion technology from the ...Learn More
Laminoplasty fixation system debuted by RTI Surgical
The Release Laminoplasty Fixation System has been introduced by RTI Surgical for use in laminoplasty procedures. ...Learn More
FDA OKs MRI pacing system from Boston Scientific
The FDA has given Boston Scientific approval for its ImageReady MR-Conditional Pacing System, which includes the Accolade ...Learn More
FDA clears AtriCure's left atrial appendage exclusion system
The FDA has granted AtriCure 510(k) clearance for its AtriClip Pro2 left atrial appendage exclusion system. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
You probably wouldn't worry about what people think of you if you could know how seldom they do!
Olin Miller, ...Learn More
AdvaMed applauds US trade rep's move against Chinese export subsidies
AdvaMed has lauded US Trade Representative Michael Froman for successfully urging the World Trade Organization to ban ...Learn More
For more:
Read the statement from AdvaMed President and CEO Scott Whitaker praising the US Trade Representative's actions over China's ...Learn More
Zimmer Biomet reaches deal to buy Cayenne Medical
Zimmer Biomet has agreed to acquire Cayenne Medical for undisclosed terms. ...Learn More
B. Braun to invest in Fla. facility expansion
Funding round pulls in $8.73M for Novacyt
A round of funding has brought in $8.73 million for cancer and infectious disease diagnostics company Novacyt. ...Learn More
J&J exec joins Flex Medical Solutions as president
John Carlson has been named president of Flex Medical Solutions, a unit of Flextronics International. ...Learn More
Novocure gets FDA IDE approval for glioblastoma therapy device
The FDA has given Novocure investigational device exemption to conduct an 85-patient Phase II pilot trial evaluating the ...Learn More
Clinical quality improvement project begins for W.L. Gore's hernia biomaterial
The first surgical procedure in a trial of W.L. ...Learn More
Siemens Healthcare wins FDA clearance for brain MRI applications
The FDA has given Siemens Healthcare clearance for its Simultaneous Multi-Slice and GoBrain applications, which are intended ...Learn More
Bill would streamline Medicare coverage for new medical technologies
A bill that would automatically grant three-year Medicare coverage for breakthrough FDA-approved medical technologies using ...Learn More
For more:
Read the AdvaMed news release commending the House for introducing legislation that would streamline the CMS' reimbursement ...Learn More
FDA clears Exactech's device for ankle arthritis treatment
Gainesville, Fla.-based Exactech has secured 510(k) clearance from the FDA for its Vantage Total Ankle, a device intended ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
You are too important to the bigger picture to just fall off the canvas.
Johnnie Dent, ...Learn More
Funding round pulls in $39M for Fresenius
A round of equity financing involving three investors has brought in $39 million for Waltham, Mass.-based Fresenius, ...Learn More
Deal to acquire Interactive Motion Technologies finalized by Bionik
Interactive Motion Technologies, a provider of robotic solutions for neurorehabilitation, has been acquired by Toronto-based ...Learn More
S.C. firm obtains $3.2M from funding round
A round of financing has pulled in $3.2 million for Greenville, S.C.-based ChartSpan Medical Technologies, bringing the ...Learn More
Amniox Medical's wound allografts score reimbursement win from Palmetto
Amniox Medical has secured reimbursement coverage from Palmetto Medicare for the use of its Neox Cord 1k and Neox 100 wound ...Learn More
German medical device maker unveils N.C. facility
Germany-based medical device company Raumedic has opened a 13,000-square-foot manufacturing facility and US headquarters in ...Learn More
NIH awards $3.5M for NYU radiology research
The NIH has awarded NYU Langone Medical Center a $3 million grant to study the reduction of the radiation dose of CT scans ...Learn More
Royal Philips introduces patient monitor with new platform
The IntelliVue patient monitoring platform with the Masimo rainbow SET technology has been unveiled by Royal Philips. ...Learn More
Sterilization containers launched by Becton Dickinson
The Genesis Low Temperature Rigid Sterilization Container System has been introduced by Becton Dickinson for use in the ...Learn More
Congressman: Proposed rules will protect medical devices from cyberattack
Rep. ...Learn More
EU expands approval for eNeura's migraine treatment device
European regulators have granted eNeura a wider CE mark approval expanding the label of its SpringTMS to include migraine ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Whatever it takes to finish things, finish. You will learn more from a glorious failure than you ever will from something you never finished.
Neil Gaiman, ...Learn More
Stryker completes CareFusion portfolio purchase, reports Q1 profit growth
CareFusion's vertebral compression fracture portfolio, which includes minimally invasive systems for vertebroplasty and ...Learn More
Funding round could pull in $3M for Baltimore medical device maker
A round of Series A financing has brought in $1.5 million, with a potential $1.5 million in additional funding, for ...Learn More
Cepheid taps Medline in US distribution deal
Medline has reached a deal to distribute the GeneXpert platform and 20 Xpert tests from Cepheid to non-acute care ...Learn More
Medtech says it has sold 10 robotic surgical systems in Q3
Ten ROSA robotic surgical systems from Medtech Innovative Surgical Technology have been sold in the US, China and France ...Learn More
Q1 sales rise for Danaher
Danaher generated $5.39 billion in sales during the three months ending April 1, up 15% from the same period a year earlier. ...Learn More
Trial shows positive results for SI-BONE's joint fusion implant
A 172-patient, 26-site study published in the International Journal of Spine Surgery showed positive results for SI-BONE's ...Learn More
Medtronic's ablation balloon catheter debuts in US
The Barrx 360 Express radiofrequency ablation balloon catheter has been released by Medtronic in the US. ...Learn More
3D breast biopsy system from Hologic cleared by FDA
The FDA has given Marlborough, Mass.-based Hologic 510(k) clearance for its Affirm, a table-based biopsy system for 3D ...Learn More
Cartiva's cartilage implant wins positive vote from FDA panel
Premarket approval has been recommended by the FDA's Orthopaedic and Rehabilitation Devices Panel for the Cartiva Synthetic ...Learn More
Canada OKs stent graft from W.L. Gore
Health Canada has given W.L. Gore & Associates approval to market its Excluder iliac branch endoprosthesis. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Quality means doing it right when no one is looking.
Henry Ford, ...Learn More
Auris Surgical to acquire Hansen Medical in $80M deal
Auris Surgical Robotics has reached a deal to acquire Hansen Medical, a Mountain View, Calif.-based intravascular robotics ...Learn More
Funding round pulls in $29.4M for G-Therapeutics
A round of Series A financing has brought in $29.4 million for G-Therapeutics, a spinoff from Switzerland-based Ecole ...Learn More
ResApp obtains $9.74M from offering
An offering of shares has pulled in $9.74 million for Australia-based ResApp, maker of a smartphone-based system that uses ...Learn More
Financing round brings in $5.75M for Bone Biologics
A round of funding has brought in $5.75 million for Boston-based Bone Biologics. ...Learn More
R-Biopharm, HMNC to develop diagnostic test for depression therapy
R-Biopharm has agreed to collaborate with HMNC Brain Health to develop an in vitro diagnostic test that detects ABCB1 gene ...Learn More
AngioDynamics announces leadership changes
Michael Trimarchi will resign as vice president and interim chief financial officer of AngioDynamics, according to a filing ...Learn More
Study shows positive results for Medtronic's insertable cardiac monitor
A study presented at the 68th American Academy of Neurology's annual meeting showed positive results for Medtronic's Reveal ...Learn More
Hand piece for prostate surgeries debuted by Bovie Medical
The J-Plasma compatible Precise 360 hand piece has been introduced by Bovie Medical for prostate surgery procedures. ...Learn More
EU OKs Boston Scientific's subcutaneous implantable defibrillator system
European regulators have given Boston Scientific CE mark approval to market its Emblem MRI subcutaneous implantable ...Learn More
FDA clears CT scanner from Toshiba
The FDA has granted Toshiba America Medical Systems clearance for its Aquilion Lightning CT system. ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Avoiding and Managing FDA Compliance Problems webinar
May 9 | 1:00 p.m.-2:00 p.m. ...Learn More
Problems are only opportunities in work clothes.
Henry Kaiser, ...Learn More
IPO could bring in $11.5M for Calif. medical device maker
An initial public offering that could raise up to $11.5 million has been filed by Sunnyvale, Calif.-based Viveve Medical. ...Learn More
InfusAID sells infusion pump assets to InfuSystem
An InfuSystem Holdings unit has entered a deal with InfusAID for infusion pump assets, in which InfuSystem will acquire 400 ...Learn More
Sisu Global Health gets $200K boost
Baltimore-based Sisu Global Health, maker of the Hemafuse device that recycles blood from patients with internal bleeding, ...Learn More
Tenn. company reaches licensing deal with Toray Industries
Toray Industries has agreed to manufacture, market and sell worldwide the Occlusion Perfusion Catheter from Chattanooga, ...Learn More
Canon unit to offer Materialise 3D printing software in Japan
Canon Lifecare Solutions has reached a deal with Belgium-based Materialise to distribute the latter's Mimics Innovation and ...Learn More
Q1 sales rise for Roche Diagnostics
Roche Diagnostics generated $2.71 billion in sales during the first quarter of 2016, up from about $2.61 billion the ...Learn More
Implantable microdevice shows promise in selecting best cancer therapy
A second-generation microdevice developed by Massachusetts Institute of Technology researchers can identify the best of 100 ...Learn More
EU launch expanded for St. Jude Medical's cardiac mapping system
St. ...Learn More
AdvaMed: India's medical device sector needs independent regulation for growth
Medical device companies in India face an impediment to growth and innovation because of price controls and the lack of an ...Learn More
Ortho Kinematics' spinal motion analyzer wins EU OK
European regulators have given Austin, Texas-based Ortho Kinematics CE mark approval to market its Vertebral Motion Analysis ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
The speed of your success is limited only by your dedication and what you're willing to sacrifice.
Nathan Morris, financial coach and ...Learn More
AdvaMed 2016 launches competition for emerging medtech companies
Early- to midstage medtech companies with innovations in the medical device, diagnostics and digital fields have until May ...Learn More
Helius Medical gets $7.2M boost
A Canadian short-form offering and a US private placement have brought in $7.2 million for Newtown, Pa.-based Helius Medical ...Learn More
Vermillion obtains $2M in 1st tranche of loan from Conn.
The Connecticut Department of Economic and Community Development has disbursed $2 million of a loan to Vermillion that could ...Learn More
Transcatheter Technologies sells tech portfolio to Venus Medtech
Venus Medtech has acquired the technology portfolio of Germany-based Transcatheter Technologies for an undisclosed amount. ...Learn More
Amedica enters exclusive distribution deal with Chinese company
Shandong Weigao Orthopedic Device Co. ...Learn More
Quest Diagnostics to offer Biocept's lung cancer test in Mexico
Quest Diagnostics has agreed to make available Biocept's Target Selector mutation detection test for lung cancer in Mexico ...Learn More
First implantation using St. Jude Medical's pacing technology recorded in US
The Saint Francis Hospital in Hartford, Conn., conducted the first US implantation of St. ...Learn More
Acelity's advanced foam dressing line debuts in US
Acelity has launched its TIELLE Foam Dressing products in the US as it seeks to expand its global role in wound care and ...Learn More
Spinal cord stimulation device from Nevro gets FDA approval
The Senza spinal cord stimulation system, a device developed by Redwood City, Calif.-based Nevro for pain alleviation, has ...Learn More
LifeBond's surgical sealant gets EU OK, expedited access status from FDA
European regulators have given Israel-based LifeBond CE mark approval to market its LifeSeal surgical gastrointestinal ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Take action. Success is not guaranteed, but inaction will guarantee failure.
Ken Poirot, ...Learn More
Offering could bring in $3B for Medtronic
An offering has been priced by Medtronic in hopes of obtaining $3 billion. ...Learn More
Ohio accelerator secures $30.75M for digital, life sciences fund
Cincinnati-based seed-stage investor CincyTech has raised $30.75 million for its CincyTech Fund IV, which will invest in ...Learn More
Financing round pulls in $30M for Organogenesis
A round of financing has brought in $30 million for Organogenesis. ...Learn More
Proteus obtains $50M from funding round
A round of funding has pulled in $50 million for Redwood City, Calif.-based Proteus Digital Health. ...Learn More
Fresenius' dialysis division becomes Fresenius Kidney Care
The dialysis division of Waltham, Mass.-based Fresenius Medical Care North America has rebranded itself as Fresenius Kidney ...Learn More
Data show positive results for Medtronic's drug-filled stent
Data from a trial presented at the American College of Cardiology Scientific Session showed positive results for Medtronic's ...Learn More
Bone fixation system debuted by Life Spine division
The TARSA-LINK Stand-Alone Wedge Fixation System, a platform intended for facilitating internal bone fracture fixation, ...Learn More
FDA releases order to reclassify cardiovascular devices
A final order has been issued by the FDA downgrading external pacemaker pulse generator devices and pacing system analyzers ...Learn More
Colorectal cancer screening blood test from Epigenomics OK'd by FDA
Epigenomics has secured approval from the FDA for its Epi proColon, a test intended for colorectal cancer screening of ...Learn More
Fractyl Laboratories' duodenal mucosal resurfacing system gets EU OK
European regulators have granted Waltham, Mass.-based Fractyl Laboratories CE mark approval to market its Revita DMR system. ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Always be a first-rate version of yourself, instead of a second-rate version of somebody else.
Judy Garland, singer and ...Learn More
Illumina pledges $100M investment in venture capital firm
Illumina Venture, a new, independently managed venture capital firm, will receive a $100 million investment from Illumina. ...Learn More
Deal to acquire NeuWave Medical completed by J&J unit
Medical device maker NeuWave Medical has been acquired by Johnson & Johnson subsidiary Ethicon. ...Learn More
Financing round pulls in $46M for RefleXion Medical
A round of Series B financing has brought in $46 million for California-based RefleXion Medical. ...Learn More
Funding round brings in $22.1M for CareDx
A private placement has pulled in about $22.1 million for CareDx. ...Learn More
CryoLife exercises $2.3M purchase option for Genesee BioMedical patch
An option to purchase the PhotoFix bovine pericardium patch from Genesee BioMedical for $2.3 million in cash has been ...Learn More
Wis. software firm obtains $550K from funding round
A round of funding led by HealthX Ventures has brought in $550,000 for EnsoData, a Madison, Wis.-based health care data ...Learn More
Aurora Spine secures patent for interspinous implants
Carlsbad, Calif.-based Aurora Spine has secured a patent from the US Patent and Trademark Office for its ZIP Interspinous ...Learn More
FDA, EU clear lab software from Luminex
Luminex has secured clearance from the FDA and CE mark approval from European regulators for its SYNCT software. ...Learn More
Silk Road Medical's transcarotid neuroprotection system cleared by FDA
The FDA has given Silk Road Medical clearance for its Enroute transcarotid neuroprotection system for use in transcarotid ...Learn More
Safe Orthopaedics product ranges approved in Australia, New Zealand
Regulators in Australia and New Zealand have given France-based Safe Orthopaedics approval for its SteriSpine ranges. ...Learn More
Avoiding and Managing FDA Compliance Problems webinar
May 9 | 1:00 p.m.-2:00 p.m. ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
A great man is always willing to be little.
Ralph Waldo Emerson, ...Learn More
Notes offering worth $1B completed by Thermo Fisher
An offering of senior notes worth $1 billion has been concluded by Thermo Fisher Scientific, according to a filing with the ...Learn More
Ill. health system launches $75M fund for health tech firms
OSF Ventures, a $75 million venture fund dedicated to investing in four to six health technology companies per year, has ...Learn More
Tekcapital unit secures rights to Stryker devices
Belluscura, a recently formed Tekcapital subsidiary, has acquired licenses to manufacture and sell three medical devices ...Learn More
Mirati signs companion Dx partnership with Qiagen
Mirati Therapeutics will work with Qiagen to develop and market a companion diagnostic test for its non-small cell lung ...Learn More
New VP for US sales named by Expanding Orthopedics
Dale Binke, a former Trinity Orthopedics executive, has been tapped to serve as vice president of US sales at Expanding ...Learn More
Trial begins for Seventh Sense's blood collection device
A study has been initiated by Seventh Sense Biosystems to compare the quality of blood samples collected by its TAP Touch ...Learn More
First implantation using Torax's continence restoration system recorded in US
The Mayo Clinic in Jacksonville, Fla., conducted the first implantation in the US of the Fenix magnetic continence ...Learn More
FujiFilm's ultrasound system gets approvals from FDA, EU
The FDA has granted Fujifilm SonoSite clearance for its SonoSite SII, a portable ultrasound system designed for use in ...Learn More
St. Jude Medical's cardiac implant gets review date from FDA advisory panel
The FDA's Circulatory System Devices Panel will meet May 24 to consider St. ...Learn More
FDA OKs spine surgery planning software from spineEOS
The FDA has granted EOS Imaging approval for its spineEOS online spine surgery 3D planning software. ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
To become a master at any skill, it takes the total effort of your heart, mind and soul working together in tandem.
Maurice Young, rapper and ...Learn More
Venture capital firm raises $208M for life sciences fund
The Forbion Capital Fund III, a fund dedicated to investments in medical device makers and other life sciences companies, ...Learn More
Financing round brings in $11.4M for Belgian implant maker
A round of Series B funding has pulled in $11.4 million for Belgium-based iStar Medical. ...Learn More
Funding round pulls in $7.5M for FIRE1
A round of Series B financing has brought in $7.5 million for Foundry Innovation & Research 1, an Ireland-based medical ...Learn More
N-of-One to provide interpretation for Admera's oncology tests
N-of-One has agreed to interpret test results generated by Admera Health's OncoGxOne 64-gene oncology panel. ...Learn More
Former Pfizer exec joins ViewRay as board member
Henry McKinnell Jr., the former chairman and CEO of Pfizer, has been tapped to serve on the board of directors at ...Learn More
Brain trauma study to use MR scanner from Toshiba
The University of California at Irvine will conduct a study to assess early indicators of chronic traumatic encephalopathy ...Learn More
Spine simulator to be launched by BioTras
The AsTris 1.0 spine simulator will be unveiled by Dallas-based BioTras at the 2016 American Society of Interventional Pain ...Learn More
Second-generation integrated therapy system unveiled by Bioness
Valencia, Calif.-based Bioness has announced the release of the second version of its integrated therapy system. ...Learn More
FDA grants clearance for AtriCure's cryoablation probe
The FDA has given atrial fibrillation device maker AtriCure clearance for its cryoFORM, a cryoablation probe that can work ...Learn More
Cardiac monitor from Biotronik gets FDA approval
The FDA has granted Biotronik premarket approval for its BioMonitor 2, a magnetic resonance imaging-compatible device for ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
I speak to everyone in the same way, whether he is the garbage man or the president of the university.
Albert Einstein, theoretical ...Learn More
Halyard Health to buy Corpak MedSystems for $174M
Halyard Health has acquired Corpak MedSystems, an enteral access solutions company, for $174 million. ...Learn More
Funding round pulls in $28.5M for Spanish diagnostics firm
A round of Series C financing has brought in about $28.5 million for Spanish clinical diagnostics company Stat-Diagnostica. ...Learn More
SafeWire product portfolio acquired by Stryker
SafeWire's product portfolio for minimally invasive spine surgery devices, which includes the Y-Wire guidewire and the Tiger ...Learn More
Boston Scientific to build manufacturing plant in Malaysia
Boston Scientific will construct a medical device manufacturing facility in Penang, Malaysia, beginning in the first half of ...Learn More
CeQur to expand workforce, headquarters in Mass.
CeQur has announced the expansion of its Marlborough, Mass., headquarters to accommodate new laboratories, a manufacturing ...Learn More
HTG Molecular secures deals to distribute products outside US
HTG Molecular Diagnostics has entered into distribution deals with two companies for its next-generation sequencing-based ...Learn More
NIH backs studies of Profusa's tissue-integrated biosensors
The NIH has awarded San Francisco-based Profusa a $1.75 million grant under its Small Business Innovation Research program. ...Learn More
Neurostimulator system from St. Jude Medical debuts in US
The Axium Neurostimulator System, a device designed to provide dorsal root ganglion stimulation for treatment of patients ...Learn More
Spinal fixation system unveiled by RTI Surgical with new instrumentation
RTI Surgical's Streamline TL Spinal Fixation System has been launched with deformity instrumentation to treat adults with ...Learn More
Profound Medical's prostate ablation device gets EU approval
European regulators have granted Toronto-based Profound Medical CE mark approval for its Tulsa-Pro, a minimally invasive ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Individual commitment to a group effort -- that is what makes a team work, a company work, a society work, a civilization work.
Vince Lombardi, ...Learn More
Funding round pulls in $4.3M for EmboMedics
A round of Series A1 financing has brought in $4.3 million for Maple Grove, Minn.-based EmboMedics. ...Learn More
Financing round brings in $2.9M for Windgap Medical
A round of debt and options financing involving 46 unnamed investors has pulled in $2.9 million for Windgap Medical, ...Learn More
Grifols enters $100M deal to buy stake in plasma collector
Spanish firm Grifols has reached a deal to purchase a 49% stake in the US plasma collector Interstate Blood Bank for about ...Learn More
Merger between Mach7, 3D Medical completed
A merger of Vermont-based data management firm Mach7 Technologies and Australia-based 3D printing company 3D Medical is ...Learn More
Medical device accelerator launched in Ind.
The AcceLinx initiative has been introduced by orthopedics industry booster OrthoWorx to provide selected entrepreneurs ...Learn More
Chief financial officer, executive VP to retire from DJO Global
Susan Crawford is retiring as executive vice president and chief financial officer at DJO Global. ...Learn More
US patent issued to 4WEB Medical for implant designs
The US Patent and Trademark Office has granted 4WEB Medical a patent covering its Programmable Truss Implant Technology. ...Learn More
Advanced Surgical Concepts' containment system gets FDA OK
Advanced Surgical Concepts has been approved by the FDA to market its PneumoLiner, a containment bag for tissues removed ...Learn More
FDA clears Tenex Health's surgical device for tendinosis
The FDA has granted Tenex Health 510(k) clearance for its TX2 MicroTip, a disposable surgical instrument for managing ...Learn More
BioFire secures FDA clearance for more panels on PCR system
The FDA has given BioMerieux unit BioFire Diagnostics clearance for use of its high-throughput FilmArray Torch platform with ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Simplicity is the keynote of all true elegance.
Coco Chanel, fashion ...Learn More
Impella heart pumps win FDA approval for treating cardiac shock
Abiomed has secured approval from the FDA for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD for treatment of ...Learn More
Funding round could pull in $11.5M for Edap
A direct-placement deal with institutional investors could bring in about $11.5 million for French therapeutic ultrasound ...Learn More
GeneNews obtains $431K in funding
The first tranche of a private placement has brought in about $431,000 for Canadian molecular diagnostics firm GeneNews. ...Learn More
Thermo Fisher reaches technology integration deal with Siemens Healthcare
A strategic partnership has been formed between Thermo Fisher Scientific and Siemens Healthcare to integrate Thermo Fisher's ...Learn More
New vice president of R&D named by TranS1
Brandon Arthurs has been promoted to vice president of research and development at Denver-based TranS1, where he previously ...Learn More
FDA OKs study of Monteris' system for medically refractory epilepsy
The FDA has granted Monteris Medical investigational device exemption clearance to conduct a trial evaluating the safety of ...Learn More
Trial begins for ReCor Medical's renal denervation device
The first 292 patients in a trial of the Paradise renal denervation device, intended for treating hypertension, have been ...Learn More
Tissue-covered heart valve debuted by St. Jude Medical in EU
The Trifecta GT aortic valve replacement, a tissue-covered device intended for treating faulty or damaged aortic heart ...Learn More
FDA expands use of 2 K2M spinal systems
The MESA Mini and DENALI Mini spinal systems from K2M Group Holdings have been cleared by the FDA for an additional ...Learn More
Ortho Kinematics passes FDA audit, secures ISO certification
Austin, Texas-based Ortho Kinematics has secured ISO 13485:2003 certification. ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
To improve is to change, so to be perfect is to have changed often.
Winston Churchill, ...Learn More
Leadless pacemaker from Medtronic approved by FDA
The FDA has given Medtronic approval for its 1-inch Micra Transcatheter Pacing System, a leadless pacemaker intended for ...Learn More
Medtronic says it won't be affected by tax inversion rules
The Treasury Department's new rules governing tax inversion deals are not expected to financially affect Medtronic, the ...Learn More
Amedica, Riverside reach debt exchange deal
Amedica has agreed to swap $1 million of the outstanding principal amount of Riverside Merchant Partners' term loan for a ...Learn More
Tyber Medical obtains $362.5K loan
Tyber Medical, a maker of orthopedic implants, has secured a 10-year loan worth $362,500 from the Pennsylvania Industrial ...Learn More
Marubun agrees to distribute MC10's biometric sensors in Japan
Marubun and Lexington, Mass.-based MC10 to have reached a deal to distribute the latter's BioStamp sensor products in Japan. ...Learn More
Baxter plans shutdown of Colo. manufacturing plant
Baxter International intends to shut down its manufacturing facility in Douglas County, Colo., in the next 12 months, ...Learn More
Studies show positive results for BrightWater's nephroureteral stent system
Three preclinical model studies being presented this week at the Society of Interventional Radiology's annual meeting showed ...Learn More
Virtual reality system for neurosurgery unveiled by Surgical Theater
A virtual reality visualization platform for neurosurgery has been introduced by Surgical Theater at a technology conference ...Learn More
AdvaMed: CMS joint replacement model could affect patient care
The CMS launched a demonstration last week at hospitals in 67 geographic areas for a new five-year Medicare payment model ...Learn More
FDA clears Advanced Brain Monitoring's sleep apnea test
Advanced Brain Monitoring's Sleep Profiler PSG2 has secured 510(k) clearance from the FDA. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Should-haves solve nothing. It's the next thing to happen that needs thinking about.
Alexandra Ripley, ...Learn More
Deal to acquire Physio-Control completed by Stryker
The $1.28 billion acquisition of Bain Capital's Physio-Control has been completed by Stryker. ...Learn More
Senior notes offering could bring in $1B for Thermo Fisher
An offering of senior notes has been priced by Thermo Fisher Scientific in hopes of obtaining $1 billion. ...Learn More
Funding round pulls in $2.25M for Biop Medical
A round of Series A financing has brought in $2.25 million for Israel-based Biop Medical. ...Learn More
Acquisition of Brightree finalized by ResMed
The $800 million acquisition of Atlanta-based cloud health care software company Brightree by San Diego-based ResMed is ...Learn More
Intelemage acquired by Medidata
Intelemage, a medical image sharing and workflow management firm, has been acquired by life sciences research technology ...Learn More
New chief medical officer, chief operations officer named by Anika Therapeutics
Stephen Mascioli, former chief medical officer at Terumo Americas Holdings, has been tapped to serve as chief medical ...Learn More
New site added by InVivo Therapeutics for neurospinal scaffold study
The University of Virginia Health System has been added by InVivo Therapeutics as a new location for the clinical trial of ...Learn More
Peripheral microcatheter debuted by Penumbra
The Lantern peripheral microcatheter, an FDA-cleared device intended for peripheral and neurovascular delivery of ...Learn More
Implanet's spine implant gets approvals from FDA, EU
The FDA has given France-based Implanet clearance for its Jazz Lock, an implant intended for use during degenerative spinal ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Those who are ill informed about change will be at risk for a rough future.
James Canton, entrepreneur and ...Learn More
Equity offerings pull in about $1.4M for InspireMD
InspireMD has secured about $1.4 million in total gross proceeds from two separate equity offerings that closed last week. ...Learn More
Sterigenics buys microbiology testing services provider
Sterigenics International has acquired Salt Lake City-based Nelson Laboratories, a provider of life cycle microbiology ...Learn More
Genomics software developer purchased by Sunquest
Cambridge, Mass.-based genomics software developer GeneInsight has been acquired by laboratory software developer Sunquest ...Learn More
DePuy unit, CareCredit sign patient financing agreement
A multiyear agreement has been signed by DePuy Synthes Mitek Sports Medicine to make Orlando, Fla.-based CareCredit the ...Learn More
New president, CEO named by AngioDynamics
James Clemmer, former president of the medical supplies segment of Covidien, has been tapped to serve as the president and ...Learn More
Study shows positive results for Edwards Lifesciences' transcatheter heart valve
A propensity-score analysis presented at the American College of Cardiology meeting in Chicago showed positive results for ...Learn More
Trial begins for LivaNova's sutureless aortic valve
The first patient in a trial of LivaNova's Perceval sutureless aortic valve has been implanted with the device. ...Learn More
NuVasive's spine surgery platform to be introduced in UK
The Integrated Global Alignment platform is expected to be launched by NuVasive in the UK at the BritSpine conference this ...Learn More
Multi-stakeholder board outlines device evaluation system plans in report
A report outlining plans for the development of a national medical device evaluation system and a coordinating center was ...Learn More
Endoscopic ablation system from CardioFocus wins FDA approval
CardioFocus has obtained premarket approval from the FDA for its HeartLight endoscopic ablation system, which is intended ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
The world is in greater peril from those who tolerate or encourage evil than from those who actually commit it.
Albert Einstein, theoretical ...Learn More
AdvaMed, others raise concerns on FDA's emerging safety signals proposal
A proposal by the FDA to release early warnings on medical device safety, even without validation or confirmation, raised ...Learn More
Elekta, GenesisCare sign $100M-plus strategic agreement
An eight-year partnership deal has been struck between Swedish medical technology company Elekta and Australian radiotherapy ...Learn More
Public offering pulls in $11.5M for Titan Medical
A public offering of shares and warrants has brought in about $11.5 million for Titan Medical. ...Learn More
Molecular diagnostics firm obtains $5M loan
Tucson, Ariz.-based HTG Molecular has secured a term loan worth $5 million under a previous deal with Oxford Finance and ...Learn More
Stryker announces completion of 2 deals
Kalamazoo, Mich.-based Stryker has announced the completion of its buyout of disposable device maker Sage Products for $2.7 ...Learn More
Expanded indication trial begins for Medtronic's heart valve system
The first patients in an expanded indication trial of the CoreValve Evolut R System, a device designed to facilitate ...Learn More
Trial for Xeltis' cardiac pulmonary valve to start soon
Xeltis is expected to begin a feasibility trial this summer of its PV-001 bioabsorbable cardiac pulmonary valve, a device ...Learn More
Radiopaque embolic bead from BTG debuts
The LC Bead LUMI, a radiopaque embolic bead designed to facilitate treatment of hypervascular tumors and arteriovenous ...Learn More
CT's risk to medical devices is very low, FDA says
Computed tomography scans put patients with implants and other medical devices at an "extremely low" risk of serious adverse ...Learn More
Vagus nerve stimulation device from electroCore gains NICE support
The gammaCore, a CE-marked vagus nerve stimulation treatment device developed by electroCore for treating migraine and ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
The person who is waiting for something to turn up might start with their shirt sleeves.
Garth Henrichs, ...Learn More
Deal to acquire Affymetrix completed by Thermo Fisher
The $1.3 billion acquisition of Affymetrix by Thermo Fisher Scientific is complete. ...Learn More
Financing round brings in $12.6M for Gauss Surgical
A round of Series B financing has pulled in $12.6 million for Los Altos, Calif.-based Gauss Surgical, bringing its total ...Learn More
Funding round pulls in $4.1M for AcuFocus
A debt financing round involving 16 unnamed investors has brought in almost $4.1 million for AcuFocus, according to a ...Learn More
Spine business grows for Implanet
French medical technology company Implanet generated about $3.2 million in revenue from its spine business in 2015, up 45% ...Learn More
Medspira signs distribution agreement for anorectal manometry system
A partnership has been formed between Medspira and Brighter Health Network to expand access to the mcompass system from ...Learn More
CardiacAssist becomes TandemLife
Pittsburgh-based medical device firm CardiacAssist has rebranded itself as TandemLife to better reflect its business, which ...Learn More
Study to test diabetes management system from Hygieia
A partnership bringing together Ann Arbor, Mich.-based Hygieia and Blue Cross Blue Shield of Michigan will test the use of ...Learn More
Siemens Healthcare poised to launch revamped hemodynamic system
The Sensis Vibe, an updated version of the Sensis hemodynamic system from Siemens Healthcare, is scheduled to be unveiled at ...Learn More
FDA OKs expanded indication for Medtronic's colon endoscopy device
The FDA has given Medtronic expanded approval for the Pillcam Colon 2, a vitamin-sized gastrointestinal imaging device ...Learn More
Aytu BioScience's male infertility Dx system wins approval in Canada
Health Canada has granted Aytu BioScience Class II medical device approval for its MiOXSYS system, a platform designed to ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
We all have ability. The difference is how we use it.
Stevie Wonder, ...Learn More
DiaSorin reaches $300M deal to buy Focus products business from Quest
Focus Diagnostics' immunoassay and molecular diagnostics products business will be acquired by Italy-based diagnostics ...Learn More
CasMed's neonate disposables acquired by Trinity in $3.35M deal
Parsippany, N.J.-based Trinity Medical Devices has acquired CAS Medical System's neonatal intensive care disposables ...Learn More
India taps Quantel for $3.4M photocoagulator lasers contract
India's Ministry of Defense has awarded French ophthalmic device company Quantel Medical a $3.4 million contract to provide ...Learn More
Public offering postponed by Sensus Healthcare
An initial public offering from Sensus Healthcare aimed at raising $20 million was postponed Wednesday. ...Learn More
New chief commercial officer named by Via Surgical
John Gomes has been tapped to serve as chief commercial officer of Israel-based Via Surgical. ...Learn More
Pilot study will assess NeuroMetrix's wearable chronic pain relief device
A partnership has been formed by NeuroMetrix and Premera Blue Cross to evaluate the Quell, an FDA-cleared wearable device ...Learn More
Smith & Nephew plans India launch for robotic surgical system
Smith & Nephew is planning a launch in India of the Navio surgical system, a platform developed by Blue Belt Technologies -- ...Learn More
Overactive bladder treatment system debuted by Medtronic
The Nuro system, a device designed to treat patients with overactive bladder, has been introduced by Medtronic. ...Learn More
X-spine gets FDA clearance for laminoplasty fixation system
The FDA has granted Xtant Medical subsidiary X-spine Systems clearance for its Xspan Laminoplasty Fixation System. ...Learn More
EU OKs wireless eye device from Retina Implant
European regulators have given Germany-based Retina Implant CE mark approval to market its Alpha AMS device, an implant ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Sometimes a player's greatest challenge is coming to grips with his role on the team.
Scottie Pippen, basketball ...Learn More
Qiagen offers to buy Exiqon for about $103.5M
A voluntary conditional public takeover offer has been submitted by Qiagen to acquire Denmark-based life science research ...Learn More
Funding round could bring in $25M for Colibri Heart Valve
Colibri Heart Valve said it intends to obtain $25 million in a Series C equity financing round. ...Learn More
Ubiquitome seeks funding for Zika test
Ubiquitome has begun a crowdfunding campaign to advance the development of its Freedom4 molecular diagnostic test platform ...Learn More
Report forecasts growth for global ultrasound devices market
A Transparency Market Research report predicts the worldwide market for ultrasound devices will reach $11 billion at a ...Learn More
Patent issued for Sanuwave's electrode design for shockwave devices
A US patent has been issued to Sanuwave Health for its electrode design intended for shockwave applicators used for ...Learn More
New cardiac leads from St. Jude Medical get EU approval
Three new Quartet left ventricular leads from St. ...Learn More
EU OKs shoulder implant from BioPoly
European regulators have granted BioPoly CE mark approval for its BioPoly RS Partial Resurfacing Shoulder System, an implant ...Learn More
FDA clears vascular intervention system from Corindus
Corindus Vascular Robotics' CorPath Robotic System has secured 510(k) clearance from the FDA. ...Learn More
Next-gen MRSA detection test from Cepheid gets EU OK
European regulators have given Cepheid CE mark approval to market its Xpert MRSA NxG, a next-generation version of its ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
And then the day came when the risk to remain tight, in a bud, became more painful than the risk it took to blossom.
Elizabeth Appell, ...Learn More
Financing deal brings in up to $45M for Veracyte
Molecular diagnostics company Veracyte has secured a financing agreement worth up to $45 million with investment firm Visium ...Learn More
BioTelemetry enters $15.5M deal to buy VirtualScopics
Medical imaging firm VirtualScopics will be acquired by wireless medical technology company BioTelemetry in a $15.5 million ...Learn More
Funding round pulls in $3.5M for RevMedx
A round of financing has brought in $3.5 million for RevMedx, maker of the XSTAT 30 wound dressing. ...Learn More
Origin Technologies drops bid to buy Affymetrix
Origin Technologies dropped its bid to acquire Affymetrix after raising its offer to $17 per share, higher than a bid of $14 ...Learn More
Report forecasts growth for global medical imaging market
A Big Market Research report predicts the worldwide medical imaging market will see a compound annual growth rate of about ...Learn More
Study shows positive results for Intuitive Surgical's robot-assisted surgical device
A cost-effectiveness study published in the journal Value in Health showed positive results for Intuitive Surgical's da ...Learn More
Direct Flow Medical's aortic valve delivery system debuts in Europe
Direct Flow Medical has introduced its DirecTrack Delivery System, a next-generation system designed to facilitate ...Learn More
FDA clears biopsy system from Merit Medical
The FDA has granted South Jordan, Utah-based Merit Medical 510(k) clearance for its Corvocet Biopsy System. ...Learn More
EU OKs knee osteoarthritis pain device from Anika Therapeutics
European regulators have given Anika Therapeutics CE mark approval to market Cingal, a medical device designed for treatment ...Learn More
Self-apposing coronary stent from Stentys gets EU approval
Regulators in Europe have given Stentys CE mark approval for its self-apposing coronary Xposition S sirolimus-eluting stent. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
A single day is enough to make us a little larger or, another time, a little smaller.
Paul Klee, ...Learn More
Royal Philips wins $77M contract modification from DOD
The Department of Defense has awarded Royal Philips a contract modification valued at as much as $77 million to continue ...Learn More
Meridian Bioscience buys Mass. test maker for $66M
Magellan Diagnostics, a Billerica, Mass.-based maker of lead detection tests, has been acquired by Ohio-based diagnostics ...Learn More
Chinese medtech firm obtains $37M investment from Goldman Sachs
Goldman Sachs has invested $37 million in China-based Venus MedTech, a maker of replacement heart valves. ...Learn More
Updated offering could bring in up to $12.1M for Titan Medical
Titan Medical's agent Bloom Burton & Co. ...Learn More
HTG, Thermo Fisher reach deal to develop diagnostic tests
HTG Molecular Diagnostics has reached an agreement with Thermo Fisher Scientific to develop in vitro diagnostic tests for ...Learn More
Report: Worldwide ultrasound market poised for growth
A MarketsandMarkets report predicts the global market for ultrasound devices will see a compound annual growth rate of 5.5%, ...Learn More
Trial advances for InVivo's neurospinal scaffold
The seventh patient in a trial of the Neuro-Spinal Scaffold, an implant designed for facilitating appositional healing in ...Learn More
Startup develops credit card-sized epinephrine injector
AdrenaCard, a medical device startup in Minneapolis, is developing an epinephrine auto-injector the size of a credit card. ...Learn More
Centralized database could improve medical device safety, quality
The FDA is working with the University of Maryland and other institutions to develop a system for collecting and analyzing ...Learn More
FDA delays decision on TransEnterix's robotic surgical device
TransEnterix said a decision from the FDA for its SurgiBot, a bedside robot-assisted surgery device intended for laparoscopy ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
AdvaMed-BRG Compliance Executive Speaker Series
April 13, Irvine, Calif. | May 18, Sunnyvale, Calif. | Sept. 14, Chicago, Ill. | Oct. ...Learn More
Always bear in mind that your own resolution to succeed is more important than any other one thing.
Abraham Lincoln, 16th US ...Learn More
AdvaMed calls on FDA to prioritize medical device guidelines
The FDA has been urged by AdvaMed to prioritize five guidance documents poised for completion in fiscal year 2016, including ...Learn More
Affymetrix, Origin to discuss $1.85B merger bid
Affymetrix said it will take part in a discussion with Origin Technologies about the latter's recent bid to acquire the ...Learn More
Xtant Medical agrees to distribute Vivex's cellular bone allograft
Xtant Medical is expected to enter the cellular bone graft market with a deal to distribute Vivex Biomedical's OsteoVive. ...Learn More
2015 sales jump for SpineGuard
SpineGuard generated $7.03 million in sales in 2015, an increase from $4.9 million in the previous year. ...Learn More
New president, CEO named by GI Dynamics
Scott Schorer, who has served as an executive for several medical device and biologics companies, has been tapped to serve ...Learn More
W.L. Gore announces new study framework for hernia biomaterial
A clinical quality improvement project has been launched by W.L. ...Learn More
Amedica creates 3D-printed structures for medical device development
Amedica said it has completed fabrication of complex 3D structures using a binderless 3D printing process known as robotic ...Learn More
FDA grants HUD designation for Xeltis' cardiac pulmonary valve
The FDA has given Xeltis humanitarian use device designation for its bioabsorbable cardiac pulmonary valve. ...Learn More
EU expands use of Baxter's surgical patch
The Hemopatch, a ready-to-use surgical patch from Baxter, has been approved by European regulators for an additional ...Learn More
FDA OKs expanded indication for Intersect ENT's sinus implant
The FDA has granted Intersect ENT expanded approval for its PROPEL mini steroid releasing sinus implant, which was initially ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
We live in a society exquisitely dependent on science and technology, in which hardly anyone knows anything about science and technology.
Carl Sagan, ...Learn More
Financing round pulls in $56.6M for ImpediMed
A private placement has brought in about $56.6 million for ImpediMed. ...Learn More
Funding round brings in $46M for Quanterix
A round of Series D funding has pulled in $46 million for Lexington, Mass.-based Quanterix. ...Learn More
Public offering boosted by InVivo Therapeutics
An additional 560,000 shares of common stock have been sold by InVivo Therapeutics from an overallotment option on its ...Learn More
Sequenom prenatal tests to be covered by Anthem
Anthem Blue Cross and Blue Shield has agreed to cover Sequenom Laboratories' noninvasive prenatal tests in Connecticut, ...Learn More
Japanese firm makes investment in medical device business
MedTecHeart's extracorporeal ventricular assist device, which uses a magnetically levitated centrifugal structure, has ...Learn More
New board member named by OraSure
Eamonn Hobbs, a co-founder of AngioDynamics and former president and CEO at Antares Pharma, has been tapped to serve on the ...Learn More
Amniox Medical reports positive findings for wound allograft
A retrospective study presented at a podiatric conference last week showed promising results for Neox, a wound allograft ...Learn More
Marketing begins for Stimwave's peripheral nerve stimulator
The StimQ Peripheral Nerve Stimulator System has been introduced by Stimwave after obtaining clearance from the FDA earlier ...Learn More
Modified breast cancer device from Dune Medical gets FDA approval
The FDA has granted Dune Medical Devices premarket approval for modifications to its MarginProbe surgical device. ...Learn More
FDA OKs wound care device from ACell
The FDA has given ACell clearance for its MicroMatrix, a device intended for covering irregular wound beds. ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
All we are not stares back at what we are.
W.H. Auden, ...Learn More
Health care investor raises $275M for medtech sector
Endeavour Vision has obtained about $275 million in committed capital for its Endeavour Medtech Growth LP fund, surpassing ...Learn More
Financing round brings in $75M for Calif. medical device maker
A round of Series C financing has pulled in $75 million for Acutus Medical, the maker of a catheter used to create 3D ...Learn More
Funding round pulls in $16.7M for Aerin Medical
A round of Series C funding has brought in $16.7 million for Aerin Medical. ...Learn More
B. Braun agrees to distribute disinfecting cap from ICU Medical
A long-term deal has been reached by B. ...Learn More
Medtronic plans transfer of manufacturing lines from Colo.
Two of Medtronic's production lines will be transferred from a Boulder, Colo., plant that manufactures electrosurgical ...Learn More
Mobile unit for stroke treatment unveiled by Tenn. college
A mobile unit that uses Siemens Healthcare's Scope CT scanner for stroke diagnosis and treatment has been introduced by the ...Learn More
Smaller transponder for cancer treatments launched by Varian Medical Systems
A Calypso 17G soft tissue Beacon transponder that measures half the size of the previous version has been launched by Varian ...Learn More
Stent, system for pancreatitis complication treatment debuted by Boston Scientific
The AXIOS Stent and Electrocautery Enhanced Delivery System has been introduced by Boston Scientific. ...Learn More
FDA advisory panel review not anticipated for Abiomed's Impella devices
Abiomed said Monday it does not anticipate the need for an FDA advisory panel review before premarket approval of its ...Learn More
SyncThink eye-tracking device gets OK from FDA
The FDA has granted SyncThink clearance for its EYE-SYNC, an integrated head-mounted device that uses virtual reality ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Everything comes to him who hustles while he waits.
Thomas Edison, ...Learn More
Senators introduce bill that would smooth FDA medical device reviews
A bill that would improve the efficiency of the FDA's reviews of medical devices has been introduced by Sens. ...Learn More
For more:
Read the AdvaMed news release commenting on Senate legislation designed to improve the effectiveness of operations at the ...Learn More
Public offering could bring in $8M for CombiMatrix
CombiMatrix is hoping to obtain $8 million in an underwritten public offering of 8,000 units of Series F convertible ...Learn More
Funding round pulls in $5.25M for Provista Diagnostics
A round of preferred funding has brought in $5.25 million for Provista Diagnostics. ...Learn More
BCBS of Mich. covers SI-BONE's joint fusion device
SI-BONE's iFuse implant, a minimally invasive device designed for sacroiliac joint fusion, has received a positive medical ...Learn More
Risk-sharing program offered by Stryker, SurgiCount
The SurgiCount Promise risk-sharing program is being offered by Stryker and SurgiCount for hospitals that use the SurgiCount ...Learn More
Daly named chairman of AdvaMed Accel
Patrick Daly, president and CEO of Cohera Medical, has been selected to serve as the chairman of AdvaMed's division for ...Learn More
US trial begins for Medinol's vessel stent
The first US patient in a trial of the NIRxcell, a bare-metal stent that uses the Flexx2 spring-tip delivery catheter and ...Learn More
Imaging software from Olea Medical cleared by FDA
The FDA has given Olea Medical clearance for its Olea Sphere 3.0, a medical imaging enterprise software intended for picture ...Learn More
FDA OKs Vermillion's blood test for ovarian cancer
The FDA has granted Vermillion clearance for its Overa, a blood test for detecting ovarian cancer risk. ...Learn More
EU OKs Luminex's herpes assay, Aries platform
European regulators have given Luminex the CE-IVD mark for its Aries System and Aries Herpes Simplex Virus 1&2 Assay. ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Thunder is good, thunder is impressive; but it is lightning that does the work.
Mark Twain, ...Learn More
IPO pulls in $45M for Senseonics
An initial public offering brought in $45 million for Senseonics. ...Learn More
Public offering extended by PAVmed
An initial public offering from PAVmed aimed at raising $6 million has been extended for 45 days. ...Learn More
"Proxy-access" policy proposed by Medtronic
Medtronic has proposed a measure that would enable shareholders holding 3% of the company's shares for at least three years ...Learn More
Report: Global implantable medical devices market poised for growth
A Market Research Store report predicts the worldwide market for implantable medical devices will see a compound annual ...Learn More
London School of Economics, ECRI collaborate to research medical device pricing
A partnership has been formed between the ECRI Institute and the London School of Economics and Political Science to study ...Learn More
First patients implanted with revision knee system recorded by Maxx Orthopedics
Patients at Brain Orthopedic Spine Specialists in Lancaster, Pa., were the first to be implanted with Maxx Orthopedics' ...Learn More
Smartphone-connected ultrasound scanner introduced by Clarius
A portable and smartphone-connected ultrasound scanner that is compatible with Apple iOS and Google Android devices has been ...Learn More
Standard template issued to boost efficiency of clinical trial review protocol
A draft protocol template developed jointly by the NIH and the FDA has been issued to enhance the protocol reviews for ...Learn More
FDA clears respiratory imaging device from PneumaCare
PneumaCare has received clearance from the FDA for its Thora-3Di imaging device for noncontact respiratory measurement. ...Learn More
Recall of Teleflex's intra-aortic device kits labeled Class I by FDA
A recall initiated by Teleflex involving over 47,000 units of its Arrow International intra-aortic balloon catheter and ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
AdvaMed-BRG Compliance Executive Speaker Series
April 13, Irvine, Calif. | May 18, Sunnyvale, Calif. | Sept. 14, Chicago, Ill. | Oct. ...Learn More
Too many people are quick to dream big, but slow to act on it.
Edmond Mbiaka, ...Learn More
Convertible debt offering brings in $634M for NuVasive
An offering of convertible notes has pulled in $634 million for San Diego-based NuVasive. ...Learn More
Baxter plans stock sale to reduce stake in biopharm firm
Baxter seeks to exchange about 59.4 million shares in Baxalta at $39.40 apiece in exchange for some of its debt held by ...Learn More
Senseonics lowers IPO target to $45M
Senseonics Holdings is hoping to obtain $45 million in a planned initial public offering, down 25% from the proceeds target ...Learn More
Baylis Medical to invest in new R&D facility
Baylis Medical is planning to build a $25.1 million research and development facility in Mississauga, Ontario, as it expands ...Learn More
New board member named by Edwards Lifesciences
Steven Loranger, a former chief executive of global water technology firm Xylem, has been tapped to serve on the board of ...Learn More
Collins: 15 ways to ensure R&D success
Research and development success can be achieved if organizations recruit and nurture creative and innovative people, keep ...Learn More
Trial begins for CorMatrix Cardiovascular's tricuspid valve
The first patient in a trial of the CorMatrix ECM triscupid valve has been enrolled by CorMatrix Cardiovascular. ...Learn More
EU regulators clear Prism Medical safety platform
Prism Medical has obtained CE mark approval for its ProteXsure Safety Capsule System. ...Learn More
FDA data show fewer medical device quality systems inspections in 2015
The FDA conducted 2,104 medical device quality systems inspections in 2015, down from 2014's total of 2,213 and down as much ...Learn More
EU OKs transcarotid neuroprotection system from Silk Road Medical
European regulators granted Silk Road Medical CE mark approval for its Enroute transcarotid neuroprotection system, a device ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
No man is wise enough, nor good enough, to be trusted with unlimited power.
Charles Colton, cleric and ...Learn More
DOD taps Zimmer Biomet for $380M orthopedic supplies contract
The Department of Defense's Defense Logistics Agency has awarded Zimmer Biomet a five-year contract valued at $380.98 ...Learn More
Public offering could bring in $1.1M for InspireMD
An underwritten public offering of 1.9 million shares has been priced by InspireMD in hopes of obtaining about $1.1 million. ...Learn More
Report forecasts growth for global peripheral vascular interventions market
A GlobalData report predicts the worldwide market for peripheral vascular interventions will increase from $2.1 billion in ...Learn More
New terms in credit facility announced by Castle Biosciences
Castle Biosciences' credit facility with Silicon Valley Bank has been raised to $14 million under new terms that refinance ...Learn More
Infusion pumps drive first-half profit growth for Smiths Medical
Smiths Group's Smiths Medical unit generated $579.9 million in sales in the six months ending Jan. ...Learn More
Boston Scientific invests millions in collaboration with Mayo Clinic
Boston Scientific has doubled its spending on a partnership with the Mayo Clinic that will conduct four "first-in-man" ...Learn More
Hammertoe reaming system introduced by Instratek
The HammerFIT Extremity Reamer System, a sterile, single-use system intended for hammertoe surgery, has been introduced by ...Learn More
AliveCor introduces EKG wrist sensor
The Kardia Band, a wrist sensor intended for monitoring heart rate and detecting atrial fibrillation, has been launched by ...Learn More
Heart valve from Edwards Lifesciences cleared in Japan
Edwards Lifesciences' SAPIEN 3, a transcatheter heart valve designed to treat patients with severe symptomatic aortic ...Learn More
FDA clears optical guidewire from Opsens
The FDA has granted Opsens clearance for its OptoWire II, an optical guidewire created to measure fractional flow reserve ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
Growth is never by mere chance; it is the result of forces working together.
J.C. Penney, ...Learn More
Funding round pulls in $45M for Spirox
A round of Series C financing led by private equity firm KKR has brought in $45 million for California-based Spirox. ...Learn More
IPO could bring in around $28M for InVivo
InVivo Therapeutics said it intends to offer 3.7 million units of common stock and warrants in an initial public offering ...Learn More
Neurostimulation unit spinoff completed by Greatbatch
Greatbatch's QiG Group has been spun off into a neurostimulation technology-focused company named Nuvectra. ...Learn More
Ophthalmic medical device maker gets $7M boost
A Series B financing round has pulled in $7 million for Menlo Park, Calif.-based Sight Sciences, the maker of the TRAB 360 ...Learn More
Financing round pulls in $26M for diagnostics firm
A round of Series B financing has brought in $26 million for diagnostics company HealthTell. ...Learn More
Trial begins for Baxter's hemodialysis device
A 20-patient clinical trial has been started by Baxter to assess the efficacy of its Vivia system for in-home and ...Learn More
Spine system debuted by Amendia
The inCORPorate, a corpectomy device for replacing a diseased vertebral body, has been introduced by Marietta, Ga.-based ...Learn More
Blood glucose monitor from LabStyle Innovations debuts in US
LabStyle Innovations' Dario system, a smartphone-connected device designed for monitoring blood glucose, has been introduced ...Learn More
Abbott's heart stent wins positive vote from FDA advisers
An FDA advisory panel has voted in favor of the safety and effectiveness of Abbott Laboratories' Absorb, a dissolving heart ...Learn More
FDA clears oxygenator from CardiacAssist
The FDA has granted CardiacAssist 510(k) clearance for its TandemLung oxygenator. ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
AdvaMed-BRG Compliance Executive Speaker Series
April 13, Irvine, Calif. | May 18, Sunnyvale, Calif. | Sept. 14, Chicago, Ill. | Oct. ...Learn More
Growth is a spiral process, doubling back on itself, reassessing and regrouping.
Julia Cameron, ...Learn More
Trunzo: Medtech industry ensures cybersecurity in connected devices
The medical technology industry puts patients' safety at the top of its priorities, ensuring that connected devices are safe ...Learn More
Funding round pulls in $12M for Arterys
A round of Series A financing has brought in $12 million for San-Francisco based Arterys. ...Learn More
Bioject's assets purchased by Inovio
Bioject Medical Technologies' assets will be acquired by Inovio Pharmaceuticals in a $5.5 million cash-and-stock deal. ...Learn More
Private placement could bring in $3.8M for GeneNews
A plan to raise up to about $3.8 million through a nonbrokered private placement of common stock has been announced by ...Learn More
Debt financing round brings in $1.4M for maker of blood collection system
A round of debt financing involving six unnamed investors has pulled in $1.4 million for Seattle-based Magnolia Medical ...Learn More
Implanet, TFS begin multicenter trial for spine correction device
A prospective, multicenter trial of Implanet's JAZZ Band, an spinal implant intended for surgical treatment of adult ...Learn More
Cardiac monitor from Biotronik debuts in UK, Ireland
Biotronik's BioMonitor 2, a subcutaneous insertable cardiac device, has been introduced in the UK and Ireland. ...Learn More
Medtech says it has sold robotic brain surgery systems in US, China
Three ROSA Brain robotic surgery systems from Medtech have been sold in the US and China, the company said. ...Learn More
FDA clears new stapling devices from Intuitive Surgical
The FDA has granted Intuitive Surgical clearance for its da Vinci Xi EndoWrist Stapler 30 instruments and reloads, which are ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
All change is not growth, as all movement is not forward.
Ellen Glasgow, ...Learn More
Senior notes offering could bring in $550M for NuVasive
An offering of 2.25 percent convertible senior notes due in 2021 has been priced by NuVasive at an aggregate principal ...Learn More
Avinger looks to sell up to $50M worth of stock
Avinger has filed for an offering of shares worth up to $50 million. ...Learn More
Avita Medical, Sinopharm reach distribution deal
A deal has been reached between Sinopharm and Avita Medical to allow Sinopharm's MedTech subsidiary to exclusively ...Learn More
Trial begins for NeoTract's treatment for benign prostatic hyperplasia
The first patient in a trial of the UroLift system, a treatment option for patients with benign prostatic hyperplasia, has ...Learn More
Patent issued for BioTras' spine simulator
A US patent has been issued to Dallas-based BioTras for its AsTris 1.0 spine simulator. ...Learn More
FDA clears Cochlear's sound processor
Cochlear's Baha 5 SuperPower sound processor has been approved by the FDA for US commercialization. ...Learn More
Medicrea's real-time lab services used in more than 500 surgeries
Medicrea's UNiD Lab Services, intended to provide spine surgeons real-time support in preoperative planning, have been used ...Learn More
Boston Scientific's open-irrigated catheter lands FDA approval
The FDA has granted Boston Scientific approval to market its Blazer open-irrigated radiofrequency ablation catheter, a ...Learn More
FDA grants clearance for Cepheid's in vitro diagnostic test
Cepheid has received clearance from the FDA for its Xpert Carba-R. ...Learn More
Mobile C-arm systems from Siemens Healthcare cleared by FDA
The FDA has granted Siemens Healthcare 510(k) clearance for the new models in its Cios mobile C-arm product line. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
The scientific man does not aim at an immediate result. He does not expect that his advanced ideas will be readily taken up. His work is like that of the planter -- for the future. His duty is to lay the foundation for those who are to come, and point...
Nikola Tesla, physicist, engineer and ...Learn More
Notes offering worth $3.5B completed by Stryker
An offering of senior notes worth $3.5 billion has been concluded by Stryker. ...Learn More
GEC tests drive Q4 revenue growth for Veracyte
Veracyte generated $14 million in revenue in the quarter ending Dec. ...Learn More
Biocept, Progenetics reach distribution deal
Cancer genomics company Progenetics has agreed to market and distribute Biocept's Target Selector liquid biopsy assays in ...Learn More
Medtronic begins trial for lung device in Europe
The first European patient in a study of the superDimension lung device has been enrolled by Medtronic. ...Learn More
Medtech closes first US sale of robotic spinal surgery system
The first US sale of the ROSA Spine robotic surgery system, intended for use in minimally invasive spine surgeries, has been ...Learn More
Cayenne Medical platform for rotator cuff repair debuts
The BioWick technology platform has been introduced by Cayenne Medical for use with the company's BioWick SureLock Implant. ...Learn More
FDA grants expanded indication for Edwards LifeSciences' heart valve
The SAPIEN CT transcatheter heart valve, a minimally invasive device developed by Edwards LifeSciences for multiple ...Learn More
EU OKs MR-conditional labeling for St. Jude Medical's leadless pacemaker
European regulators have given St. ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
Don't find fault -- find a remedy.
Henry Ford, ...Learn More
Bills to accelerate medtech approval OK'd by Senate panel
A slate of bills that would facilitate FDA review of medtech approvals was approved Wednesday by the Senate Health, ...Learn More
NuVasive to offer convertible notes in $550M funding round
NuVasive has announced a plan to sell convertible senior notes that will be due in 2021 to raise $550 million in a financing ...Learn More
Next-gen sequencing technology maker gets $80M boost
Lasergen, a developer of next-generation sequencing technology, has received an $80 million investment from Agilent ...Learn More
Commercial tests drive Q4 revenue growth for Biocept
Biocept generated $218,000 in revenue in the quarter ending Dec. 31, up from $76,000 in the same period in 2014. ...Learn More
US patent expanded for LabStyle Innovations' blood glucose monitor
LabStyle Innovations has secured expanded patent protection from the US Patent and Trademark Office for its Dario Blood ...Learn More
Lumbar interbody device from Wenzel Spine debuts
The VariLift-LX System, an implantable device intended for minimally invasive lumbar fusion procedures, has been introduced ...Learn More
Nitinol bone fixation system from BioMedical Enterprises debuts
The Elite, a nitinol bone fixation device, has been released in the US by San Antonio-based BioMedical Enterprises. ...Learn More
FDA clears interbody system from Life Spine
Life Spine's PROLIFT Expandable Interbody System, a minimally invasive solution for patients with spinal disorders, has ...Learn More
Posterior fixation device from NuVasive wins approval in Japan
Japanese regulators have given NuVasive approval to commercialize Reline, a posterior fixation system, in that country. ...Learn More
Digital mammography manual from American College of Radiology gets FDA OK
The alternative standard request filed by the American College of Radiology for use of the Digital Mammography Quality ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
AdvaMed-BRG Compliance Executive Speaker Series
April 13, Irvine, Calif. | May 18, Sunnyvale, Calif. | Sept. 14, Chicago, Ill. | Oct. ...Learn More
There is only one thing that makes a dream impossible to achieve: the fear of failure.
Paulo Coelho, ...Learn More
Senseonics to float 18.2M shares in IPO
Senseonics said it intends to offer 18.2 million shares in an initial public offering with the goal of raising $60 million. ...Learn More
Becton Dickinson to sell majority stake in respiratory business
Apax Partners will purchase a 50.1% stake in Becton Dickinson's respiratory business, and the two will create a joint ...Learn More
NIH supports development of interbody fusion device
The NIH's National Institute on Aging has awarded Carmel, Ind.-based Nanovis a research grant to evaluate its FortiCore, an ...Learn More
Tricare to cover CareDx's heart transplant test
Tricare has agreed to provide reimbursement coverage for CareDx's AlloMap, a test designed for heart transplant rejection. ...Learn More
Accessioned tests drive Q4 revenue growth for Natera
Natera generated $52.9 million in revenue in the quarter ending Dec. ...Learn More
InVivo includes new site for neurospinal scaffold study
InVivo Therapeutics has added Thomas Jefferson University Hospital in Philadelphia as a new location for a study of its ...Learn More
Wearable device to boost mobility in blind patients being developed by Toyota
A wearable device is being developed by Toyota to improve the indoor navigation and mobility of the visually impaired and ...Learn More
EU OKs annuloplasty device from BioStable Science
Regulators in Europe have given BioStable Science & Engineering CE mark approval to market its HAART 300, a device designed ...Learn More
Pulmonary embolism device from Inari Medical gets FDA IDE status
The FDA has granted an investigational device exemption to Inari Medical for a study of the FlowTriever, a ...Learn More
China OKs cytology test from Roche
The CINtec PLUS Cytology test, developed by Roche, has received approval from Chinese regulators. ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
Only he who attempts the absurd is capable of achieving the impossible.
Miguel de Unamuno, writer and ...Learn More
Stock sale pulls in $13.9M for Stentys
Stentys has secured $13.9 million in an offering of 5.6 million company shares. ...Learn More
Soft tissue microwave ablation device maker acquired by Ethicon
Ethicon, a unit of Johnson & Johnson, agreed to pay an undisclosed sum to purchase NeuWave Medical. ...Learn More
Brazilian firm purchased by NuVasive
San Diego-based NuVasive has agreed to pay an undisclosed amount to acquire its Brazilian distributor, Mega Surgical. ...Learn More
Flatley to resign as CEO of Illumina
Jay Flatley will resign as CEO of Illumina in July but will take the role of executive chairman, the company said. ...Learn More
Trial begins for Medtronic's transcatheter aortic valve system
The first patients in a trial of the CoreValve Evolut R system, which is intended to treat severe aortic stenosis in ...Learn More
Groups work on making Zika tests for blood screening
Three biotech firms, Grifols Diagnostic Solutions, Roche Molecular Diagnostics and Hologic, are working with the American ...Learn More
Interbody devices from Medtronic debut
The AVILA, a family of interbody fusion devices for L2-S1 levels in ALIF and OLIF procedures that are open and minimally ...Learn More
Sensimed's contact lens sensor lands FDA clearance
The Triggerfish, a contact lens sensor developed by Sensimed, has received clearance from the FDA. ...Learn More
FDA grants IDE approval for Corvia Medical's interatrial shunt device
The FDA has given Corvia Medical investigative device exemption approval to study the effectiveness of its InterAtrial Shunt ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Goals allow you to control the direction of change in your favor.
Brian Tracy, ...Learn More
Senior notes offering could bring in $3.5B for Stryker
An offering of senior notes has been priced by Stryker in hopes of obtaining $3.5 billion. ...Learn More
Mindray Medical completes privatization deal
Mindray Medical International has completed a deal with its management to go private through a merger with Solid Union. ...Learn More
Zimmer Biomet, CelgenTek reach distribution deal
Zimmer Biomet has entered into a deal to globally distribute CelgenTek Innovation's N-Force Fixation System and iN3 cement. ...Learn More
Sirona Genomics acquired by Immucor
Immucor, a transfusion and transplantation diagnostics firm, has agreed to pay an undisclosed sum to purchase Stanford ...Learn More
Q4 revenue increases for Roka Bioscience
Molecular diagnostics company Roka Bioscience generated $1.5 million in revenue in the quarter ending Dec. ...Learn More
First treatment in US using gamma knife device recorded by Elekta
A US patient was the first to be treated for a metastatic brain tumor using Elekta's Leksell Gamma Knife Icon. ...Learn More
Enhanced ultrasound system from Hitachi Aloka debuts
The Arietta V70, an ultrasound technology with improved elastography functions, has been introduced by Hitachi Aloka ...Learn More
FDA releases guidance on IDE for neurological devices
Draft guidance has been published by the FDA to help sponsors file investigational device exemptions to perform clinical ...Learn More
Lumbar cage from Stryker cleared by FDA
The FDA has granted Stryker clearance to market its Tritanium PL, a posterior lumbar cage designed to help in lumbar spinal ...Learn More
FDA clears blood pressure monitor from SunTech, AtCor
The Oscar 2, an ambulatory blood pressure monitor developed by AtCor Medical and SunTech Medical, has received clearance ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
Status quos are made to be broken.
Ray Davis, ...Learn More
Medos International to design spine implant with Rainbow Medical
Medos International Sarl, which is part of Johnson & Johnson's DePuy Synthes Cos., is partnering with Rainbow Medical, a ...Learn More
NovoCure's brain cancer device scores reimbursement win from Humana
Humana will cover the use of Optune, a mobile device developed by NovoCure for treatment of recurrent glioblastoma. ...Learn More
Martin resigns as president, CEO of Cardiovascular Systems
David Martin has stepped down as president and CEO of Cardiovascular Systems. ...Learn More
FDA OKs iliac branch endoprosthesis from W.L. Gore
The Gore Excluder, an iliac branch endoprosthesis from W.L. Gore & Associates, has received approval from the FDA. ...Learn More
First-in-human robot-assisted surgical device use recorded by Virtual Incision
Virtual Incision said its miniaturized robotically assisted surgical device has performed the first-in-human operation by a ...Learn More
Canada OKs pressure ulcer scanner from Bruin Biometrics
A medical device license was granted by Health Canada to Bruin Biometrics for the firm's SEM Scanner, a hand-held device ...Learn More
FDA urges medtech firms to provide more information on refurbished devices
The FDA is calling on medtech firms to provide more data on products that are repaired, serviced, remanufactured, ...Learn More
MR surgical leads from Medtronic land FDA clearance
The Specify SureScan MR surgical leads developed by Medtronic have obtained clearance from the FDA. ...Learn More
EU OKs 2 products from Xtant Medical
Regulators in Europe have given Xtant Medical CE mark approval to market its Irix-A, a standalone anterior lumbar fusion ...Learn More
2nd Annual AdvaMed Payment Policy Conference
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In a gentle way, you can shake the world.
Mahatma Gandhi, social ...Learn More
Equity funding round pulls in $28M-plus for Retina Implant
A round of private equity financing has brought in about $28.2 million for Germany-based Retina Implant. ...Learn More
Prosthetic attachment system acquired by Zimmer Biomet
Zimmer Biomet has agreed to pay an undisclosed sum to purchase Ortho Transmission as well as its transcutaneous osseous ...Learn More
Radiology Protocols secures imaging technology deal with GE Healthcare
A partnership was formed between GE Healthcare and Radiology Protocols to integrate the latter's imaging management system ...Learn More
J&J life sciences incubator launched in Houston
Johnson & Johnson Innovation on Wednesday opened its fifth JLABS facility in the US. ...Learn More
Microfluidic device developed to examine red blood cells
A microfluidic device equipped with a computer algorithm that could monitor sickle cell disease progression has been ...Learn More
Magnetic field tool assessed for cell preservation
Japanese researchers reported in the journal Neuroscience Research that preserving human induced pluripotent stem ...Learn More
Clinical video system from Orpheus gets FDA clearance
A clinical video and imaging documentation system developed by Orpheus Medical has received clearance from the FDA. ...Learn More
New medical device standards have 3-year phase-in period
A revision to ISO 13485 by the International Organization for Standardization increases the emphasis on quality management ...Learn More
FDA clears radiation dose tracker from Elekta
The iViewDose, a radiation dose tracker from Elekta, has obtained clearance from the FDA. ...Learn More
Abbott releases safety notice on MitraClip system use
A safety notice concerning the deployment process of the MitraClip Delivery System was released by Abbott after the company ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
AdvaMed-BRG Compliance Executive Speaker Series
April 13, Irvine, Calif. | May 18, Sunnyvale, Calif. | Sept. 14, Chicago, Ill. | Oct. ...Learn More
What is now proved was once only imagined.
William Blake, poet and ...Learn More
J&J's LifeScan reaches mobile tech deal with WellDoc
WellDoc has secured a partnership deal with LifeScan, a unit of the Johnson & Johnson Diabetes Care Cos., to collaborate on ...Learn More
Merck to design companion Dx test with NanoString
Seattle-based NanoString Technologies is partnering with Merck to design and market a companion diagnostic test for Merck's ...Learn More
Q3 revenue increases for Medtronic
Medtronic generated $6.9 billion in revenue in the quarter ending Jan. ...Learn More
Idaho wound care center adds advanced diagnostic technology
The Gritman Wound Healing Center in Moscow, Idaho, is among those installing a new imaging device that allows doctors to ...Learn More
New technology simplifies ultrasound images
Princeton graduate student Jen-Tang Lu developed a technology that works with all ultrasound devices, combining physics, ...Learn More
Interbody fusion technology from Stryker debuts
The Aero-C, a cervical interbody fusion device and cervical stability system, has been introduced by Stryker. ...Learn More
Ureteral stent tracker app from Boston Scientific debuts
Boston Scientific has introduced the Ureteral Stent Tracker, a HIPAA-compliant app that helps urologists monitor and ...Learn More
Olympus agrees to resolve kickback claims for $623.2M
Olympus has reached a $623.2 million settlement with the Justice Department to resolve civil and criminal allegations that ...Learn More
EU OKs blood separation device from Becton Dickinson
Regulators in Europe have given Becton Dickinson CE mark approval to market its Vacutainer Barricor, a next-generation blood ...Learn More
FDA OKs ceramic femoral heads from CoorsTek Medical
CeraSurf-p ceramic femoral heads, developed by CoorsTek Medical, have obtained approval from the FDA. ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
AdvaMed-BRG Compliance Executive Speaker Series
April 13, Irvine, Calif. | May 18, Sunnyvale, Calif. | Sept. 14, Chicago, Ill. | Oct. ...Learn More
It's not always necessary to be strong, but to feel strong.
Jon Krakauer, ...Learn More
Outside ownership repurchased by Pyrexar
Pyrexar Medical has repurchased the 20% outside ownership of its company that was acquired by life sciences company Perseon ...Learn More
Deal to acquire outreach lab service business completed by Quest Diagnostics
Quest Diagnostics has concluded its purchase of Clinical Laboratory Partners, Hartford HealthCare's outreach laboratory ...Learn More
Atlas Spine enters pivoting spacer technology deal with Spine Wave
Atlas Spine has agreed to license its True Position, a pivoting spacer system, to Spine Wave. ...Learn More
Instruments, consumables drive Q4 revenue growth for NanoString
NanoString Technologies generated $22.3 million in revenues in the quarter ending Dec. ...Learn More
How drug, device makers are allocating marketing budgets
Pharmaceutical, biotechnology, health diagnostics and medical device companies' marketing budgets are relatively stable, but ...Learn More
ISO certification granted to Event Cardio Group
Event Cardio Group, a maker of medical equipment for preventing and diagnosing high-risk diseases, has been granted ISO ...Learn More
EU OKs spine surgery planning software from EOS Imaging
Regulators in Europe have given EOS Imaging CE mark approval to market its spineEOS, a 3D planning software designed for ...Learn More
FDA clears dosimetry system from ScandiDos
The Delta Discover, a dosimetry technology from Sweden-based ScandiDos, has obtained clearance from the FDA. ...Learn More
Amendment to InVivo's neurospinal scaffold study OK'd by FDA
The FDA has approved Cambridge, Mass.-based InVivo Therapeutics to make changes to the 20-patient study of its Neuro-Spinal ...Learn More
Skull clamp warning issued by FDA
A safety notice was issued by the FDA about movement or slippage of neurosurgical clamps during surgeries. ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
And the little screaming fact that sounds through all history: repression works only to strengthen and knit the repressed.
John Steinbeck, ...Learn More
Financing round pulls in $17M for Vivify Health
A round of funding led by health care provider and insurer UPMC has brought in $17 million for Vivify Health. ...Learn More
Seed funding round pulls in $1.7M for Versago Vascular Access
A round of seed financing from Primo Medical Group investors has brought in $1.7 million for West Bridgewater, Mass.-based ...Learn More
Mindray's management buyout approved by shareholders
A management-led buyout plan to take Mindray Medical International private has obtained approval from the medtech firm's ...Learn More
A&E Medical acquired by private equity firm
Vance Street Capital, a Los Angeles-based private equity firm, has agreed to pay an undisclosed sum to purchase A&E Medical. ...Learn More
2 new board members named by RTI Surgical
Curtis Selquist and Dr. Peter Gearen have been tapped to serve on the board of directors at RTI Surgical. ...Learn More
EU OKs Zika virus detection tool from Bioneer
Regulators in Europe have given South Korean molecular diagnostics company Bioneer the CE-IVD mark for its AccuPower ZIKV ...Learn More
Medical refrigeration-monitoring device from Emanate debuts
The PowerPath Temp, a health care refrigeration-monitoring device, has been released by Emanate Wireless. ...Learn More
FDA clears vascular access device from Teleflex
The Arrow VPS Stylet, a device developed by Limerick, Pa.-based Teleflex for vascular access operations, has received 510(k) ...Learn More
ASTORA Women's Health gains FDA panel support for female fecal incontinence implant
The FDA's Gastroenterology and Urology Devices Panel has endorsed ASTORA Women's Health's TOPAS, an implantable surgical ...Learn More
Medical tablet from Dictum Health cleared by FDA
The IDM Medical Tablet, a portable tablet developed by Dictum Health to monitor cardiopulmonary data and vital signs, has ...Learn More
Defining Value Webinar: Implications of New Value Frameworks for Devices
March 4 | WebinarDuring this one-hour webinar, you will hear an update on comparative effectiveness research in the US. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Being powerful is like being a lady. If you have to tell people you are, you aren't.
Jesse Carr, labor union ...Learn More
Share buyback program initiated by Anika Therapeutics
Anika Therapeutics has announced it will buy back $25 million in stock as part of an accelerated share repurchasing plan ...Learn More
GE enters deal to create funding for 2 Accuray systems
A collaborative deal has been struck by GE Healthcare to create options for financing Accuray's TomoTherapy and CyberKnife ...Learn More
2015 net sales jump for Wright Medical
Wright Medical Group generated $415 million in net sales in 2015, an increase from $298 million in the previous year. ...Learn More
New chairman named by Boston Scientific
Michael Mahoney has been selected to serve as board chairman at Boston Scientific. ...Learn More
Brazilian researchers, Luminex team up to validate Zika virus assay
University of Sao Paulo researchers in Brazil have teamed up with Luminex to validate a Zika virus detection panel from ...Learn More
Firms partner to create knee replacement product
Invibio Knees and Maxx Orthopedics have partnered to create a PEEK-OPTIMA-based femoral knee replacement device. ...Learn More
EU OKs digital PCR system from Bio-Rad
Regulators in Europe have given Bio-Rad's QX200 Droplet Digital PCR technology the CE-IVD mark. ...Learn More
FDA clears higher throughput PCR system from BioFire Diagnostics
The Film Array Torch, a higher throughput multiplex PCR technology developed by BioFire Diagnostics, has obtained special ...Learn More
FDA clears cardiac mapping device from APN Health
The Navik 3D, a cardiac mapping technology from APN Health, has received clearance from the FDA. ...Learn More
Class I recall of Beacon Tip catheters widened by Cook Medical
A recall involving its Beacon Tip Angiographic Catheters has been expanded by Cook Medical to include more lots of the ...Learn More
Women's Executive Network Webinar: Executive Profiles
March 29 | WebinarDuring the one-hour webinar, two senior leaders in the medical device industry, Cathy Burzik and Judy ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Without courage we cannot practice any other virtue with consistency.
Maya Angelou, writer and civil rights ...Learn More
AdvaMed welcomes Senate confirmation of Califf as FDA chief
The Senate voted 89-4 to confirm the appointment of cardiologist Robert Califf as the next FDA commissioner. ...Learn More
Financing round pulls in $22M for Biodesix
Biodesix has raised $22 million via a Series F sale of preferred stock and securities. ...Learn More
Stock sale pulls in $11.4M for Reva Medical
A sale of shares to Goldman Sachs International has brought in $11.4 million for Reva Medical. ...Learn More
Funding round stretched by Spectral Medical to $10.5M
An additional 806,804 shares have been sold by Toronto-based Spectral Medical from an overallotment option on its recent ...Learn More
First transplant using OCS liver system recorded by TransMedics
A patient at Massachusetts General Hospital was the first to receive a transplanted liver using the OCS Liver system from ...Learn More
Russian, Chinese patents issued to Proa Medical for vaginal retractor
The Brella, a vaginal retractor from Redondo Beach, Calif.-based medtech firm Proa Medical, has obtained patents in Russia ...Learn More
Synthetic grafts from Leader Biomedical debut
The OssGro range of synthetic grafts designed to simulate new bone formation has been released by Leader Biomedical. ...Learn More
Quadripolar left ventricular leads from Boston Scientific get FDA OK
Boston Scientific's ACUITY X4 quadripolar left ventricular leads have received approval from the FDA. ...Learn More
EU OKs wound filler from CollPlant
Regulators in Europe have given CollPlant CE mark approval to market its Vergenix, a flowable gel intended to address acute ...Learn More
AdvaMed seeks measures to boost medtech in India
AdvaMed has asked Arun Jaitley, India's finance minister, to add provisions in the country's budget that would improve ...Learn More
FDA Submissions Strategy
March 9-10 | Sunnyvale, Calif.Effective navigation of the FDA application process requires an approach that is both ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
We cannot change the cards we are dealt, just how we play the hand.
Randy Pausch, computer scientist and ...Learn More
Software firm acquired by ResMed in $800M deal
San Diego-based respiratory device company ResMed has agreed to pay $800 million in cash to purchase Brightree, a ...Learn More
Titan Medical gets $1.1M boost
An additional $1.1 million has been raised by Toronto-based Titan Medical from an overallotment option on its recent ...Learn More
Optical imaging firm acquired by SpectraScience
San Diego-based SpectraScience has agreed to pay an undisclosed sum to purchase the assets of Oncoscope, a Durham, ...Learn More
Product sales drive Q4 revenue growth for GenMark Diagnostics
GenMark Diagnostics generated $13.2 million in revenue in the quarter ending Dec. ...Learn More
Anterior cervical fixation device from RTI Surgical debuts
The Unison-C, an anterior cervical fixation technology, has been released by Alachua, Fla.-based RTI Surgical. ...Learn More
Texas researchers develop rapid detection test for Zika virus
Researchers at Texas Children's Hospital and Houston Methodist Hospital have developed the first rapid detection test for ...Learn More
Total hip arthroplasty device from OrthoGrid Systems debuts
The HipGrid Drone, a delivery technology that includes the HipGrid direct posterior and anterior total hip arthroplasty, has ...Learn More
Coverage groups asked to join FDA's medtech presubmission meetings
Payer groups such as health technology assessment bodies and private health insurance firms are being urged by the FDA to ...Learn More
EU OKs annuloplasty system from Mitralign
Regulators in Europe have given Mitralign CE mark approval to market its Mitralign percutaneous annuloplasty device. ...Learn More
Clinical decision support tool from Euformatics gets EU OK
European regulators have granted CE mark approval to Euformatics for its omnomicsNGS, a tool that interprets genetic ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Winning is not a sometime thing; it's an all the time thing. You don't win once in a while; you don't do things right once in a while; you do them right all of the time. Winning is a habit. Unfortunately, so is losing.
Vince Lombardi, football ...Learn More
Financing round pulls in $12M for ALung
A funding round has brought in $12 million for ALung Technologies, a Pittsburgh-based maker of an artificial lung-like ...Learn More
Firms conclude deal to create injectable drug delivery systems
A $75 million deal to develop injectable drug delivery technologies has been finalized by Unilife and Amgen. ...Learn More
Lateral lumbar interbody fusion, cervical artificial disc replacement markets poised for growth
A Research and Markets report predicts the market for cervical artificial disc replacement will expand through 2020 at a ...Learn More
New CFO named by Bruker
Anthony Mattacchione has been tapped to serve as CFO of MRI maker Bruker. ...Learn More
Renal denervation device from ReCor Medical gets FDA IDE status
The FDA has granted an investigational device exemption to ReCor Medical for a study of the firm's Paradise, a renal ...Learn More
Wearable biosensors from Royal Philips to debut
Royal Philips said it expects to launch wearable medical-grade biosensors that are designed to monitor at-risk patients who ...Learn More
Canada OKs 2 technologies from Luminex
Medical device licenses were granted by Health Canada's Therapeutic Products Directorate to Luminex's Aries Herpes Simplex ...Learn More
EU OKs peripheral stent from Boston Scientific
Regulators in Europe have given Boston Scientific CE mark approval to market its Eluvia, a peripheral vessel stent intended ...Learn More
Airway management system from Hospitech cleared by FDA
The AnapnoGuard 100, an airway management device from Israel's Hospitech Respiration, has obtained clearance from the FDA. ...Learn More
Health technology firms urge legislators to approve medtech bill
Health IT vendors including McKesson, athenahealth and IBM are asking for bipartisan support for the Medical Electronic Data ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
The distance between insanity and genius is measured only by success.
Bruce Feirstein, ...Learn More
Pentagon taps Calmare for $15M pain therapy device contract
The Department of Defense has awarded Calmare Therapeutics, a Fairfield, Conn.-based pain mitigation firm, a 60-month ...Learn More
Stock offering could pull in about $6.3M for Great Basin Scientific
Great Basin Scientific is hoping to secure about $6.3 million in gross proceeds and $5.6 million in net proceeds in a public ...Learn More
Etta Healthcare purchased by OvaGene Oncology
OvaGene Oncology has agreed to pay an undisclosed sum to purchase Etta, a health care diagnostics company. ...Learn More
Former Royal Philips exec named CEO, board chairman of MedyMatch
Gene Saragnese has been tapped to serve as board chairman and CEO at MedyMatch Technology, an Israel-based artificial ...Learn More
US patent issued to Silver Bullet's antimicrobial bone implants
Silver Bullet Therapeutics has obtained a patent from the US Patent and Trademark Office for its bone implants designed to ...Learn More
Catheter, nitinol guidewire from Nipro debut in US
The Cronus HP, a high-pressure over-the-wire transluminal angioplasty balloon catheter, has been launched in the US by ...Learn More
Patent issued for IntelGenx migraine treatment film
IntelGenx has obtained a patent from the US Patent and Trademark Office for its Rizaport, an oral rizatriptan benzoate film ...Learn More
Dosimetry technology from ScandiDos cleared by FDA
The Delta4 Discover, an in vivo dosimetry technology from ScandiDos, has obtained 510(k) clearance from the FDA. ...Learn More
Resorbable bone wax from Wound Management unit lands FDA clearance
HemaQuell Resorbable Bone Wax, a water-soluble material from Wound Management Technologies' Resorbable Orthopedic Products ...Learn More
EU OKs human leukocyte antigen typing software from GenDx
Regulators in Europe have given NGSengine software by GenDx, a Dutch genetic testing company, the CE-IVD mark. ...Learn More
Technical Writing for Regulatory Submissions
March 8 | Sunnyvale, Calif. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Desire is the starting point of all achievement.
Napoleon Hill, ...Learn More
AdvaMed taps BIO's Whitaker to be CEO
Scott Whitaker has been selected to serve as the next CEO of AdvaMed effective April 4. ...Learn More
For more:
Read the news release from AdvaMed about its new CEO, Scott ...Learn More
Equity offering pulls in $2.4M for Vicarious Surgical
An equity offering involving 11 investors has brought in $2.4 million for Cambridge, Mass.-based Vicarious Surgical. ...Learn More
Q4 revenue increases for MDxHealth
MDxHealth generated $5.7 million in revenue in the quarter ending Dec. ...Learn More
Fertility, miscarriage tests drive Q4 revenue growth for CombiMatrix
CombiMatrix generated $2.7 million in revenue in the quarter ending Dec. ...Learn More
FDA clears blood collection system from BD
The BD Vacutainer UltraTouch, a push-button blood collection device from BD, has received 510(k) clearance from the FDA. ...Learn More
Patient monitoring platform gets FDA clearance
Root, a patient monitoring and connectivity system from Masimo, has received 510(k) clearance from the FDA. ...Learn More
PACS software from Fujifilm cleared by FDA
Fujifilm Medical Systems' Synapse 5 PACS software has obtained 510(k) clearance from the FDA. ...Learn More
FDA urged to require cybersecurity from device makers
The FDA has failed to provide enforceable regulations that safeguard medical devices from cyberattacks, according to a ...Learn More
Europe expands approval for Z-Medica's hemostatic devices
European regulators have given expanded approval to Z-Medica for its QuikClot kaolin-based hemostatic devices. ...Learn More
Thyroid test from Rosetta Genomics gets approval in N.Y.
Rosetta Genomics' RosettaGX Reveal, a thyroid cancer diagnostic test, has been approved by the New York State Department of ...Learn More
PMA Submissions Workshop
Feb. 25-26 | Irvine, Calif. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Live daringly, boldly, fearlessly. Taste the relish to be found in competition -- in having to put forth the best within you.
Henry Kaiser, ...Learn More
SpineGuard signs group purchasing deal with Hospital Corp. of America
The Hospital Corp. ...Learn More
Q4 revenue increases for Affymetrix
Santa Clara, Calif.-based Affymetrix generated $95.6 million in total revenue in the quarter ending Dec. ...Learn More
New CFO, vice president named by J-Pac Medical
Michael Dolge has been tapped to serve as CFO of J-Pac Medical, a Somersworth, N.H.-based maker of implantable textiles and ...Learn More
Study begins for AtriCure's left atrial appendage closure system
The first patient in a clinical study of AtriClip, a left atrial appendage closure device, has been enrolled by West ...Learn More
Study: Orcas' health app shows promise in depression symptoms treatment
A study conducted by Orcas found its MoodHacker cognitive behavioral therapy-based application was more effective in helping ...Learn More
FDA clearance sought by Avantis for colonoscopy device
Avantis Medical Systems has filed an application with the FDA seeking 510(k) clearance for the use of its Third Eye ...Learn More
Neurostimulator from St. Jude gets FDA approval
The Axium, a neurostimulator technology developed by St. Jude Medical, has obtained premarket approval from the FDA. ...Learn More
Clearance for Medtronic's deep-brain stimulation device widened by FDA
The FDA has granted Medtronic expanded 510(k) approval for its deep-brain stimulation technology to be used for a wider ...Learn More
Australia OKs glucose monitor from Abbott
The FreeStyle Libre, a glucose monitoring device from Abbott, has received approval from Australia's Therapeutic Goods ...Learn More
California Proposition 65 Webinar: What to Know and What's Ahead
Feb. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
A business has to be involving, it has to be fun, and it has to exercise your creative instincts.
Richard Branson, businessman, investor and ...Learn More
Physio-Control acquired by Stryker in $1.28B deal
Stryker has agreed to purchase Redmond, Wash.-based external defibrillator manufacturer Physio-Control from Bain Capital for ...Learn More
Report forecasts global market growth for portable X-ray systems
A Mordor Intelligence report predicts the worldwide portable X-ray device market will reach $4.1 billion by 2020, with a ...Learn More
Interbody fusion devices drive worldwide sales growth for Titan Spine in 2015
Titan Spine generated $33.5 million in sales worldwide in 2015. ...Learn More
Functional body parts created in 3D printer, researchers say
A 3D printer has produced living, functional body parts used on animals in what scientists call a breakthrough for ...Learn More
Transcatheter mitral valve from Direct Flow Medical debuts
The Direct Flow Medical Transcatheter Mitral Valve, which is intended to fight structural heart disease, has been released ...Learn More
Digital radiography system from Konica Minolta debuts in Mexico
The AeroDR LT digital radiography technology from Konica Minolta Medical Imaging has been introduced in Mexico. ...Learn More
EU OKs glaucoma laser technology from Iridex
Regulators in Europe have given Mountain View, Calif.-based Iridex CE mark approval to market its Cyclo G6, a laser device ...Learn More
Ultrasound, CT fusion device from Clear Guide lands FDA clearance
The Scenergy, an ultrasound, CT fusion and image guidance system from Clear Guide Medical, has received 510(k) clearance ...Learn More
Wound closure adhesive from Chemence gets FDA clearance
The FDA granted 510(k) clearance to Chemence Medical's Exofin, a topical adhesive intended for closing wounds. ...Learn More
IDE Submissions Workshop
Feb. 24 | Irvine, Calif. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
If anything is worth trying at all, it's worth trying at least 10 times.
Art Linkletter, radio and TV ...Learn More
Funding round pulls in $4.2M for JustRight Surgical
A round of Series B financing has pulled in $4.2 million for JustRight Surgical. ...Learn More
Eisai collaborates with Sysmex on dementia Dx test development
Eisai has signed a nonexclusive collaboration deal with Sysmex to develop next-generation diagnostics for dementia. ...Learn More
Medtech firm opens Dx IVD facility in India
India-based Trivitron Group has opened a new Labsystems Diagnostics IVD plant at the Trivitron Medical Technology Park in ...Learn More
Researchers create portable deep-space Dx tool
A team of six researchers from NASA's Ames Research Center, Sandia National Laboratories/California and the University of ...Learn More
Research team uses cotton candy maker to develop capillary system
A cotton candy machine was used by Vanderbilt University professor Leon Bellan and his team of researchers to create a 3D ...Learn More
Konica Minolta designs EHR-integrated imaging platform
Konica Minolta is entering the EHR market with the launch of an imaging platform at the HIMSS16 meeting. ...Learn More
Prequalified IVD reporting guidelines released by WHO
A draft guidance was issued by the World Health Organization on what IVD makers must report under its prequalification ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Don't wait until conditions are perfect to begin. Beginning makes conditions perfect.
Alan Cohen, writer and motivational ...Learn More
Priority areas for regulatory cooperation in trade pact identified by US, European groups
Medtech groups from the US and Europe, including AdvaMed, MITA, Eucomed, EDMA and COCIR, are calling for regulatory ...Learn More
For more:
Read the AdvaMed press release calling for regulatory cooperation in ...Learn More
Funding round pulls in $15M for Regentis Biomaterials
A round of Series D financing led by Haisco Pharmaceutical Group has brought in $15 million for Regentis Biomaterials. ...Learn More
Stock offering brings in $7.6M for Titan Medical
Toronto-based Titan Medical raised $7.6 million in a stock offering of 11.7 million shares. ...Learn More
Oxford Performance enters spine technology platform deal with RTI Surgical
Oxford Performance Materials has agreed to license its OsteoFab spine technology platform to RTI Surgical. ...Learn More
Q4 revenue increased for ConforMIS
ConforMIS generated $19.1 million in revenue in the fourth quarter of 2015, a 34% increase over the same period a year ...Learn More
Valtech's mitral regurgitation device scores reimbursement win in Germany
The use of Valtech Cardio's Cardioband Mitral Reconstruction System, a sutureless implant intended to address mitral ...Learn More
FDA clears retina imaging technology from Optovue
The AngioVue, an optical coherence tomography angiography device from Optovue, has obtained clearance from the FDA. ...Learn More
Bridge fixation system from Zimmer Biomet gets FDA clearance
The FDA granted 510(k) clearance to Zimmer Biomet's Unite3D, a fixation system intended for foot and ankle joint fusion. ...Learn More
BTG gets FDA clearance for radiopaque embolic bead
The LC Bead Lumi, a radiopaque embolic bead from BTG, has received 510(k) clearance from the FDA. ...Learn More
Medtronic's insulin pump therapy system gains NICE support
The UK's National Institute for Health and Care Excellence has issued a decision recommending the use of Medtronic's MiniMed ...Learn More
California Proposition 65 Webinar: What to Know and What's Ahead
Feb. ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Nothing endures but change.
Heraclitus, ...Learn More
Regentis' Series D funding hits $15M
Regentis Biomaterials has obtained $15 million from its recent Series D round of financing led by Haisco Pharmaceutical ...Learn More
Hemovent obtains $6M from Series A funding round
Hemovent has closed its Series A round of financing with $6 million from investors led by MIG Verwaltungs. ...Learn More
Avita taps MSM Medical in distribution agreement
Avita Medical has secured a deal with MSM Medical in which MSM will distribute Avita's full line of products, including its ...Learn More
Drew Distin fills VP post at Tissue Regenix offshoot
Drew Distin has been tapped to serve as the vice president of Tissue Regenix Orthopaedic, North America starting March 1. ...Learn More
Report predicts growth for small bone, joint devices market
A Transparency Market Research report projected the value of the worldwide small bone and joint devices market will hit $8.2 ...Learn More
OptiOne CT system from Guerbet gets FDA clearance
The FDA granted 510(k) clearance to Guerbet's OptiOne single-head CT contrast delivery platform. ...Learn More
FDA clears lumbar interbody fusion device from Wenzel Spine
The VariLift-LX, developed by Wenzel Spine, has received clearance from the FDA. ...Learn More
FDA clears compression staple from MX Orthopedics
The dynaMX Compression Staple, designed by MX Orthopedics, has received clearance from the FDA. ...Learn More
Japanese regulators clears Biotronik's MRI-safe CRT-D
The Itrevia 7 HF-T cardiac resynchronization therapy defibrillator, developed by Biotronik, has been cleared by Japanese ...Learn More
Pressure monitors, catheters, trays recalled by Cook Medical
Catheter tip separation or fracture prompted Cook Medical to pull 17,827 single lumen central venous catheters and pressure ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
510(k) Submissions Workshop
Feb. 22-23 | Irvine, Calif. ...Learn More
If you were born without wings, do nothing to prevent them from growing.
Coco Chanel, fashion ...Learn More
Amended offering could pull in up to $8M for Titan Medical
Titan Medical has changed the size of its upcoming offering from 8.9 million shares to as much as 12.2 million shares. ...Learn More
Synergetics USA's neuro devices purchased by Stryker
Stryker has agreed to acquire the assets of Synergetics USA's neuro portfolio. ...Learn More
Report: Worldwide market for spinal trauma devices set for growth
The global market for spinal trauma devices is anticipated to grow through 2023, an SBWire report says. ...Learn More
Oncotype DX test drives Q4 revenue growth for Genomic Health
Genomic Health generated $74.5 million in revenue in the quarter ending Dec. ...Learn More
Firms will partner to develop in vitro cancer Dx tool
A strategic deal was reached between Thermo Fisher Scientific and Invivoscribe Technologies to create an in vitro cancer ...Learn More
Wedge implant from Tyber Medical debuts
The TyWedge Osteotomy Wedge Systems, a titanium plasma sprayed PEEK wedge implant, has been released by Tyber Medical. ...Learn More
FDA clears HIV/AIDS diagnostic tool from Becton Dickinson
The FACSPresto system and CD4/Hb cartridge, developed by Becton Dickinson as an HIV/AIDS diagnostic, has received 510(k) ...Learn More
MRI patient monitoring device from Royal Philips lands FDA clearance
The Expression MR400, a technology developed by Royal Philips to monitor magnetic resonance imaging patients, has obtained ...Learn More
Drager Medical's transport ventilator recall labeled Class I by FDA
A recall initiated by Drager Medical involving 117 units of its Oxylog 2000 plus, Oxylog 3000 and Oxylog 3000 plus emergency ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
AdvaMed Women's Executive Network Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. D.C., for our inaugural WEN Conference. ...Learn More
Immense power is acquired by assuring yourself in your secret reveries that you were born to control affairs.
Andrew Carnegie, ...Learn More
Deal to acquire Avita's respiratory unit completed by Medical Developments International
Medical Developments International has concluded its purchase of Avita Medical's respiratory business for nearly $2.5 ...Learn More
Funding round extension pulls in $3.5M for Velano Vascular
An additional $3.5 million was raised by Velano Vascular in a Series A funding round extension. ...Learn More
CMS to cover use of Boston Scientific's left atrial appendage closure device
Boston Scientific's Watchman device, designed for use in left atrial appendage closure therapies, will receive Medicare ...Learn More
Smith & Nephew reaches distribution deal with OrthAlign
A deal has been reached by Smith & Nephew to distribute OrthAlign's KneeAlign device in 21 countries throughout the Middle ...Learn More
Trial begins for Medtronic's stent graft
The first patient in a study of the Valiant TAAA, a stent graft technology intended to address thoracoabdominal aortic ...Learn More
High-speed cell analyzer from BD debuts
The BD FACSymphony, a high-speed cell analyzer that can measure as many as 50 different characteristics in a single cell, ...Learn More
Vital sign monitoring system from LifeWatch gets FDA clearance
Vital Signs, a monitoring system from Swiss remote diagnostic monitoring firm LifeWatch, has obtained 510(k) clearance from ...Learn More
7 bills tied to device, drug regulations advanced in Senate
The Senate Health, Education, Labor and Pensions Committee has advanced seven measures that would strengthen FDA oversight ...Learn More
For more:
Read the AdvaMed news release praising the Senate HELP Committee for the FDA Device Accountability ...Learn More
FDA clears extracellular matrix biomaterial from CorMatrix Cardiovascular
The Tyke, an extracellular matrix biomaterial developed by CorMatrix Cardiovascular for infants and neonates, has received ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
9th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
May 3-4 | Arlington, Va.This annual workshop brings together leading authorities from the FDA, industry and academia to ...Learn More
Be ashamed to die until you have won some victory for humanity.
Horace Mann, educator, abolitionist and ...Learn More
Medtech companies tweak strategies as prices tumble
Strong competition in the medtech sector has led to declining prices for many medical devices, and hospitals face increasing ...Learn More
Funding round pulls in $6M for Via Surgical
A round of financing led by Benslie Investment Group has brought in $6 million for Israel-based Via Surgical. ...Learn More
Implanet America names new president
Brian Ennis has been tapped to serve as president of Implanet America. ...Learn More
First patient implanted with lateral lumbar cage recorded by VGI Medical
A patient at Flagler Hospital in Florida was the first to be implanted successfully with VGI Medical's VerteLP Lateral ...Learn More
Canada approves catheter tip location system from AngioDynamics
The Celerity PICC Tip Confirmation System with Navigation, a tip location technology developed by Latham, N.Y.-based ...Learn More
Optical coherence tomography technology from St. Jude debuts
The OPTIS Mobile System, which combines angiography co-registration and optical coherence tomography with fractional flow ...Learn More
Occlusion balloon from Spectranetics lands FDA clearance
The Bridge, an occlusion balloon from Colorado Springs, Colo.-based Spectranetics, has obtained 510(k) clearance from the ...Learn More
Obama seeks funding to create Zika vaccine, fight virus
President Barack Obama will request more than $1.8 billion in funding from Congress to fight the spread of the Zika virus in ...Learn More
EU OKs point-of-care platform, chlamydia test from Atlas Genetics
Regulators in Europe have given Atlas Genetics the CE-IVD mark for its io point-of-care platform and Chlamydia trachomatis ...Learn More
Meeting date set for FDA advisory panel to review cartilage implant from Cartiva
The FDA's Orthopaedic and Rehabilitation Devices Panel will convene April 20 to consider Cartiva's bid for premarket ...Learn More
AdvaMed Innovation Summit
March 30-31 | Washington, D.C. ...Learn More
Statistical Methods in Economic Evaluations Workshop
May 2 | Arlington, Va. Economic evaluations play an integral role in informing health care policy decisions. ...Learn More
Adaptability is about the powerful difference between adapting to cope and adapting to win.
Max McKeown, writer and leadership ...Learn More
Secondary shares offering could bring in $1.1B for Zimmer Biomet
Orthopedics company Zimmer Biomet is planning to sell 11 million shares in a secondary offering with the goal of securing ...Learn More
Share-buyback program initiated by Edwards Lifesciences
Edwards Lifesciences has entered into a deal to buy back $350 million in stocks from Morgan Stanley as part of a $750 ...Learn More
Offering could pull in about $5.8M for Titan Medical
Titan Medical said it intends to offer 8.9 million shares in an offering aimed at securing $5.8 million. ...Learn More
Biotronik, Maquet reach US distribution deal
A deal has been reached by Maquet Medical Systems to distribute the peripheral vascular devices of Berlin-based Biotronik in ...Learn More
Report forecasts growth for global digital X-ray market
A MarketsandMarkets report predicts the worldwide digital X-ray systems market will reach $10.46 billion by 2020, with an ...Learn More
First treatment using live-image guided embolic beads recorded by BTG, Philips
The first instance of a liver cancer patient being treated with BTG's LC Bead LUMI embolic beads together with Philips' 2D ...Learn More
Lombard Medical records first use of endovascular stent graft
A patient at the UK's University Hospital of South Manchester was the first to undergo endovascular repair using Lombard ...Learn More
N.Y. facility to evaluate cardiac rehabilitation tool's effectiveness
A clinical trial to evaluate the effectiveness of Moving Analytics' MOVN app beyond three months of use by cardiac ...Learn More
Study: Sentinel platform, iPod tool show promise in matching patients to their EHRs
An FDA-funded study said the agency's Sentinel database and iPod Touch-based app called the Hand-held Automated Notification ...Learn More
2 MRI-safe defibrillators from Medtronic get FDA approval
Medtronic's Compia and Amplia MRI Quad SureScan cardiac resynchronization therapy defibrillator devices have been approved ...Learn More
2nd Annual AdvaMed Payment Policy Conference
April 6-7 | Arlington, Va.The current reimbursement and coverage landscapes for medical devices and the potential impact of ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
April 27-28 | Washington, D.C. ...Learn More
Having just the vision's no solution; everything depends on execution.
Stephen Sondheim, composer and ...Learn More


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In the News
Building A Better Valve
By: New York Times | June 2015

The F.D.A. approved the new Edwards valve for high-risk patients; it had been available only in clinical trials. Medtronic also has a new version of its valve that cardiologists expect will soon be approved. 

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Plasma Makes Wounds Heal Quicker
By: Medical Design Technology | June 2015

Many people suffer from skin disorders. Open wounds are a particularly acute problem, especially among the elderly. PlasmaDerm, a new medical technology solution, uses plasma to facilitate faster healing of wounds.

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Wearable Device on Your Ear Controls Blood Loss
By: Medical Design Technology | June 2015

While neural stimulation technologies have been around for some time now, it seems the technology is just finally beginning to mature into the form of medical devices that can make a real impact on the lives of those who most desperately need them. 

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Toddler Walking With New Prosthetic Leg
By: NBC News | June 2015

A toddler undergoes a successful amputation below his left knee and learns to walk with a prosthetic leg.

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