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IPO could bring in $54M for Vital Therapies
Vital Therapies seeks to obtain $54 million in an initial public offering of 4.5 million company shares valued at $12 each. ...Learn More
Inspiro Medical acquired by Opko Health
Inspiro Medical has been acquired by respiratory drug maker Opko Health for undisclosed terms. ...Learn More
Calif. surgical-device maker seeks $43.9M from stock sale
California-based Cardica hopes to raise $43.9 million through a public stock offering that could be completed next week. ...Learn More
Breast cancer detection device firm advances $10M funding round
First Warning Systems has raised $540,000 of a hoped-for $10 million financing round. ...Learn More
Danaher posts Q1 revenue growth; Culp to step down as CEO
Danaher posted $4.66 billion in revenues during the first quarter, a 5% increase over $4.44 billion during the same period ...Learn More
Calgary Scientific's imaging tool gains Chinese certification
Chinese regulators have certified Calgary Scientific to offer its ResolutionMD system to medical practitioners in China. ...Learn More
China OKs Cepheid's TB and rifampin resistance test
Cepheid has secured clearance to market the Xpert MTB/RIF test, a molecular assay used to diagnose tuberculosis and rifampin ...Learn More
Anika begins U.S. distribution of knee device
Anika Therapeutics has begun U.S. ...Learn More
Covidien's camera-equipped feeding tube gets FDA OK
The FDA has granted Covidien approval for a camera-equipped disposable feeding tube known as Kangaroo with IRIS Technology, ...Learn More
Endo Health unit receives warning letter over issues at Minn. facility
American Medical Systems, a unit of Endo Health, has received an FDA warning letter over procedural issues found at its ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Success is the sum of small efforts repeated day in and day out.
Robert Collier, American ...Learn More
TriVascular Technologies kicks off IPO
On Wednesday, stent-graft-maker TriVascular Technologies launched its initial public offering of 65 million shares valued at ...Learn More
Breast cancer Dx firm obtains $2.7M from investors
A group of backers has pumped $2.7 million into Eventus Diagnostics. ...Learn More
Startup developing mini-laparoscopic tools gets $644K boost
Miret Surgical, a spinoff of Stanford BioDesign, has secured $644,750 in a Series A financing round, said CEO John Avi Roop. ...Learn More
Heart devices helped fuel income growth for St. Jude in Q1
St. ...Learn More
Opko Health rebrands Prolor Biotech
Prolor Biotech has been rebranded by Opko Health as Opko Biologics, with Shai Novick continuing as president. ...Learn More
Firms partner to offer genetic tests in Canadian market
LifeLabs Medical Laboratory Services has entered into a marketing agreement with Contextual Genomics under which the ...Learn More
Wash. firm obtains funds to help launch heart device studies
A funding round has pulled in $20 million for Cardiac Dimensions, maker of the Carillon Mitral Contour System intended to ...Learn More
Ulrich announces U.S. launch of titanium spinal implants
The tezo line of titanium spinal implants is now available commercially in the U.S., according to ulrich medical, which ...Learn More
Device tax slows profitability, stalls acquisitions, execs say
The 2.3% medical device tax may be hindering large medtech firms from investing in merger and acquisition deals, industry ...Learn More
GS1 issues guidelines on unique device ID implementation
Supply chain standards development group GS1 has issued a guidance document meant to help medical device companies use GS1 ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
An expert is someone called in at the last minute to share the blame.
Sam Ewing, American writer and ...Learn More
Boston Scientific wins FDA nod for 4 implantable heart devices
Boston Scientific has secured FDA approval for the Inogen Mini and Dynagen Mini implantable cardioverter defibrillators, or ...Learn More
Mainstay eyes $31.7M from IPO; Lombard drops IPO plans
Mainstay Medical, an Irish firm specializing in orthopedic devices, has filed for an initial public offering in Ireland and ...Learn More
Stryker's $172M purchase of Berchtold finalized
Stryker has wrapped up its purchase of Berchtold Holding, a Germany-based maker of surgical-room equipment, for $172 ...Learn More
Opsens renews licensing deal with Abiomed
Opsens has agreed to renew an exclusive licensing deal it struck with Abiomed in 2010. ...Learn More
Vermillion on track to set up clinical reference lab
Vermillion is moving forward with plans to open a clinical reference laboratory after satisfying the necessary regulatory ...Learn More
Canadian medtech license submission forms updated
Health Canada has revised the application documents for sponsors and companies seeking licenses for Class II, III and IV ...Learn More
J&J unit's facility expansion in Ireland could add 420 jobs
Ethicon Biosurgery, a Johnson & Johnson unit specializing in hemostasis and surgical sealant devices, is setting up a ...Learn More
N.Y. state grants clinical lab permit to Almac's Dx unit
The diagnostics division of Almac can now obtain clinical samples from New York after obtaining a clinical laboratory permit ...Learn More
Misonix's ultrasonic surgical tools presented at conference
The BoneScalpel system intended to support fast, accurate and safe osteotomies was unveiled by Misonix at a recent ...Learn More
FDA approves study of Reverse Medical's aneurysm device
The FDA has granted Reverse Medical investigational device exemption approval to conduct clinical studies in the U.S. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
I am more afraid of an army of 100 sheep led by a lion than an army of 100 lions led by a sheep.
Charles Maurice de Talleyrand-Perigord, French ...Learn More
Registry launched to test Boston Scientific's device for Parkinson's
Boston Scientific said the first patient has been enrolled in a registry investigating the use of its Vercise deep brain ...Learn More
Debt funding round brings in $9M for Cerapedics
Cerapedics has secured a loan worth $9 million, part of which will go toward the company's efforts to navigate the U.S. ...Learn More
Wright Medical plans facility expansion in Arlington, Tenn.
Wright Medical, which specializes in extremity medical devices, is adding 52,000 square feet of office and warehouse space ...Learn More
Australia considers changes to device, drug-fee exemption program
The Therapeutic Goods Administration in Australia is seeking comments through May 23 on proposed changes to its low-value ...Learn More
Irish agency enters medtech R&D partnership with Mayo Clinic
The Mayo Clinic has struck a deal with Enterprise Ireland, a business and research-and-development promotion agency, to ...Learn More
Patient enrollment for Rox's hypertension device study completed
Rox Medical has finished enrolling 100 patients in a pivotal clinical study of its Rox Coupler system. ...Learn More
CT system from Toshiba certified for use on Air Force network
The Air Force has granted Toshiba America Medical Systems approval-to-operate status for its CT technology, allowing the ...Learn More
Medicrea's personalized spinal rod system makes EU debut
A spinal osteosynthesis rod system customized to each patient has been released in Europe by Medicrea. ...Learn More
FzioMed gets chance to dispute FDA's prior ruling over spinal surgery gel
FzioMed will meet with an FDA dispute-resolution panel on June 10 to consider its Oxiplex gel, designed to support healing ...Learn More
FDA clears advanced CT technology from GE Healthcare
The FDA has cleared GE Healthcare to market its Revolution system, which could be distributed worldwide starting this ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
It is easy to sit up and take notice. What is difficult is getting up and taking action.
Al Batt, American ...Learn More
Sante Ventures secures $139M health care investment fund
A regulatory filing disclosed that Sante Ventures has obtained $139 million for its latest investment fund. ...Learn More
Bio-Rad acquires DNA-sequencing technology firm
Bio-Rad Laboratories has agreed to pay an undisclosed sum to acquire GnuBIO, a Massachusetts-based maker of a droplet-based ...Learn More
Qiagen gains exclusive license for blood disorder biomarker
CeMM Vienna has agreed to allow Qiagen to exclusively license its calreticulin biomarker for undisclosed terms. ...Learn More
Koning's breast CT scanner wins approval in Canada
Health Canada has given Koning the go-ahead to market its CT scanner intended for full breast imaging with high contrast and ...Learn More
EU approves wider use of Vexim's spinal device
European regulators have granted Vexim expanded CE mark approval for its SpineJack technology. ...Learn More
Minn. startup raises $25M to further develop mitral valve device
Tendyne Holdings has obtained $25 million in a Series C round of financing led by Apple Tree Partners. ...Learn More
Ortho Development's new hip prosthesis gains FDA clearance
The FDA has granted Ortho Development clearance for its Ovation Tribute Hip Stem. ...Learn More
Advanced diagnostic monitor from NEC lands FDA clearance
The FDA has cleared NEC to market its MultiSync MD302C4 LCD medical monitor, which comes with advanced LED backlighting, a ...Learn More
FDA to meet with Guided Therapeutics over cervical device
The FDA has agreed to meet with Guided Therapeutics to consider the company's renewed bid for approval of its LuViva system ...Learn More
MRI coil from ClearMRI Solutions OK'd by FDA
The Helios-RG8 MRI coil accessory kit, developed by ClearMRI Solutions, has obtained clearance from the FDA. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
It is much easier to be a hero than a gentleman.
Luigi Pirandello, Italian ...Learn More
Covidien pays more than $100M for New Wave Surgical
Covidien has paid more than $100 million to acquire New Wave Surgical, maker of a device used to keep robotic and ...Learn More
Robust growth forecast for U.S. pain management device market
A Decision Resources Group report predicts that by 2022, the U.S. ...Learn More
Former Becton executive takes the helm of CeQur
CeQur, maker of an insulin pump for type 2 diabetes patients, has tapped Douglas Lawrence to serve as its new CEO. ...Learn More
EU approves Seno Medical's breast cancer imaging tool
Seno Medical Instruments has obtained the CE mark for the Imagio opto-acoustic imaging tool, which is used to enhance breast ...Learn More
Abbott wraps up patient enrollment in Absorb device studies
Abbott has finished enrolling some 2,800 patients in three clinical trials evaluating its Absorb system, a dissolving, ...Learn More
10 biventricular pacemakers from Medtronic gain FDA OK for wider use
Medtronic has secured expanded FDA approval for 10 of its biventricular pacemakers -- the Consulta CRT-P and CRT-D, Brava ...Learn More
Spinal surgery device from Baxano lands FDA clearance
The FDA has cleared Baxano Surgical to market the Avance MIS Pedicle Screw System, which is set for full market release ...Learn More
2 cardiac patients in Texas get help with battery-powered device
A subcutaneous internal cardioverter-defibrillator developed by Boston Scientific has brought new hope for Ruben Rivera, a ...Learn More
Wyden urged to join push for device tax repeal
Sen. ...Learn More
FDA approves RevMedX's device to stem internal bleeding
The FDA has granted RevMedX approval to market its XStat system. ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
A good example is far better than a good precept.
Dwight Moody, American preacher and ...Learn More
Medtronic clears EU hurdle for MRI-safe defibrillator
European regulators have given Medtronic the CE mark to market its Evera MRI SureScan ICD system. ...Learn More
Colo. appendicitis Dx firm receives $18.4M funding boost
Colorado-based Venaxis has obtained $18.4 million in financing, which it would use to support general corporate functions. ...Learn More
InfoBionic obtains $17M ahead of arrhythmia Dx device launch
InfoBionic has raised $17 million in the first tranche of its Series B financing round. ...Learn More
Financing round pulls in $5M for Genomind
A funding round led by Claritas Capital has brought in $5 million for Genomind. ...Learn More
Advanced Cooling Therapy wins EU nod for Esophageal Cooling Device
Advanced Cooling Therapy has earned the CE mark to market its Esophageal Cooling Device, designed to help clinicians manage ...Learn More
CardioDx taps Medison to bring CAD diagnostic test to Israel
Medison has entered into a marketing deal with CardioDx for undisclosed terms. ...Learn More
With medtech margins: Don't think price, think COGS
The prices of medical devices, whether innovative or commodity, are under significant pressure from all corners and in all ...Learn More
Firm gets $3.6M boost to further develop prostate cancer test
ProteoMedix has secured $3.62 million in a Series B financing round led by Altos Venture. ...Learn More
Bioventus announces Canadian release of next-gen bone healing device
An advanced version of the EXOGEN Ultrasound Bone Healing System is available commercially in Canada, according to ...Learn More
4 paralyzed men regain mobility, thanks to electrical stimulator
Rob Summers, Kent Stephenson, Andrew Meas and Dustin Shillcox, who have been living with paralysis because of spinal cord ...Learn More
FDA clears handheld vascular ultrasound from Analogic
The FDA has cleared Analogic to market its Sonic Window device, a handheld ultrasound system intended to give clinicians ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Fortune favors the audacious.
Desiderius Erasmus, Dutch social critic and ...Learn More
VC firm secures $1.6B for third health care fund
Deerfield Management has secured $1.6 billion for its third investment fund targeted at biotech, medical device and other ...Learn More
Calif. aneurysm-device firm obtains $20M in Series D financing
A Series D funding round headed by Delphi Ventures has brought in $20 million for Sequent Medical. ...Learn More
PCLS announces purchase of MultiGen Diagnostics
Physicians Choice Laboratory Services has agreed to pay an undisclosed sum to acquire MultiGen Diagnostics, maker of a tool ...Learn More
Financing round pulls in $12M for AdvanDx
AdvanDx has raised $12 million in a Series B-1 funding round led by Merck Global Health Innovation Fund. ...Learn More
SHL Pharma's facility expansion in Fla. could create 30 jobs
SHL Pharma plans to set up a facility in Deerfield Beach, Fla., and hire 30 additional workers within the next year, company ...Learn More
EU approves right-side heart pump from Abiomed
Abiomed has earned the CE mark to market its Impella RP system in Europe. ...Learn More
Theradiag to develop rheumatoid arthritis Dx with French groups
Theradiag has entered into a development deal with the Universities of Montpellier 1 and 2 and the French National Center ...Learn More
Ellipse reports first implantation of pediatric spinal device
A pediatric patient with progressive spinal deformity at Shriners Hospitals for Children in Philadelphia has become the ...Learn More
J&J unit introduces high-speed drill for surgical procedures
A high-speed electric surgical drill intended for use during otologic, neurological and spinal procedures has been released ...Learn More
U.S., EU OK Boston Scientific's organ-tissue collection device
Boston Scientific has received 510(k) clearance from the FDA and CE mark approval in Europe for its Expect Slimline needle. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Victory is in the quality of competition, not the final score.
Mike Marshall, American baseball ...Learn More
Exact Sciences targets $125M from stock sale
Wisconsin-based Exact Sciences is looking to obtain $125 million through a public shares offering. ...Learn More
Shares offering could bring in $8.9M for BG Medicine
BG Medicine hopes to raise net proceeds of $8.9 million through an offering of company shares valued at $1.55 apiece. ...Learn More
Md. cancer genetic test firm obtains $2.8M from investors
Personal Genome Diagnostics has secured $2.8 million from unnamed backers, which the company aims to use to develop and ...Learn More
Co-founder tapped as new president of VuCOMP
James Pike has been tapped to serve as president of VuCOMP, a maker of computer-aided breast cancer detection tools. ...Learn More
Strong growth forecast for worldwide bio-implants market
A MarketsandMarkets report predicts that the worldwide market for bio-implants will grow from $94.1 billion two years ago to ...Learn More
Minn. company gets $42M boost to conduct EU study of COPD device
Plymouth, Minn.-based Holaira has received $42 million in a round of financing led by Vertex Venture Holdings. ...Learn More
Biotronik announces first U.S. implants of Iforia defibrillator
Biotronik said its Iforia implantable cardioverter-defibrillator has been implanted for the first time in the U.S. ...Learn More
Study to evaluate Theraclion's ultrasound device gets FDA OK
The FDA has granted Theraclion investigational device exemption approval to conduct a clinical study evaluating the use of ...Learn More
FDA guidelines on device review communications finalized
The FDA has issued its final guidance governing typical communications between medical device companies and the agency ...Learn More
2 more GOP senators sign on to device-tax repeal measure
Sens. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
About the only thing that comes to us without effort is old age.
Gloria Pitzer, American ...Learn More
AccessClosure to be acquired by Cardinal Health for $320M
Cardinal Health has agreed to pay $320 million to acquire AccessClosure in a cash deal that could be finalized in June. ...Learn More
Growth forecast for image-guided tools market in U.S.
An iData Research report predicts that the U.S. ...Learn More
Calif. eye surgery device firm obtains $34.4M in financing
A group of 20 unnamed investors has pumped $34.4 million into Auris Surgical Robotics. ...Learn More
New AdvaMed chairman sets sights on global medtech harmonization
Covidien President and CEO Jose Almeida told reporters during a conference call that he will focus on efforts to harmonize ...Learn More
EU approves intraoperative CT scanner from Mobius Imaging
Mobius Imaging has earned the CE mark in Europe for its Airo Mobile Intraoperative CT system, designed to facilitate ...Learn More
Costa Rica offers training on planned online medtech registration process
The Costa Rican Ministry of Health is holding training sessions to clarify its proposed system to allow manufacturers to ...Learn More
Medtech trends: The most talked about device makers in March 2014
MassDevice.com looks at the Internet chatter surrounding the medical device industry with some of the most searched-for ...Learn More
Calif. company gets $22M boost to finalize glaucoma device study
A round of Series C financing has pulled in $22 million for Transcend Medical. ...Learn More
Bone-suppression software from Carestream lands FDA clearance
Carestream Health has been cleared by the FDA to market its bone suppression software, designed to subdue the appearance of ...Learn More
Life sciences firms feel the pinch from device tax
During a meeting this week with Sol Ross, HHS' director of private sector engagement, representatives from biotech companies ...Learn More
FDA OKs Rotation's device to repair rotator-cuff tears
The FDA has cleared Rotation Medical to market its collagen scaffold technology designed to treat patients with rotator-cuff ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
The truly free man is he who knows how to decline a dinner invitation without giving an excuse.
Jules Renard, French ...Learn More
Steris to pay about $175M for Integrated Medical Systems
Integrated Medical Systems, which specializes in surgical tools repair and offers device sterilization consulting services, ...Learn More
Venture capital firm raises $300M for second health care fund
Foresite Capital, which invests in medical device, biotech and other health care firms, has raised its second fund. ...Learn More
Providence gets $6.8M boost to advance cervical fusion device
Providence Medical Technology has obtained $6.8 million in a Series C funding round. ...Learn More
EU widens approval for Sorin's sutureless aortic valve
Sorin has earned the CE mark in Europe to expand the use of its Perceval system, a sutureless aortic valve designed to treat ...Learn More
Study yields positive results for Boston Scientific's S-ICD system
A clinical study found that patients showed 100% and 99.7% treatment rates for spontaneous ventricular tachyarrhythmias and ...Learn More
NeuMoDx obtains $21M to advance molecular diagnostics
A Series B round of financing led by Pfizer Ventures has pulled in $21 million for NeuMoDx Molecular. ...Learn More
Upgraded version of Intuitive's surgical robot gets FDA OK
The FDA has cleared Intuitive Surgical to market the latest version of its robotic surgery device called the da Vinci Xi ...Learn More
Eliminating device tax could boost R&D investment in diabetes therapy
Diabetes treatment has substantially improved in recent years, thanks to the development of glucose monitors, patch pumps ...Learn More
MannKind's inhaled diabetes treatment wins FDA panel support
An FDA advisory panel endorsed the approval of MannKind's inhaled insulin therapy Afrezza as a treatment for type 1 and type ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
How much easier it is to be critical than to be correct.
Benjamin Disraeli, former British prime ...Learn More
Ind. governor calls on Obama to support device tax repeal
Indiana Gov. ...Learn More
J&J agrees to Carlyle's $4B takeover bid for blood Dx business
The Carlyle Group's offer to acquire Johnson & Johnson's Ortho-Clinical Diagnostics business for roughly $4 billion has been ...Learn More
Lombard Medical issues price range for planned IPO
Lombard Medical Technologies, which develops stent grafts used for abdominal aortic aneurysm repair, said it will offer ...Learn More
Neb. facility adopts Konica Minolta's wireless DR system
The University of Nebraska-Lincoln University Health Center has deployed the ImagePilot Aero system from Konica Minolta ...Learn More
Japan clarifies proposed changes to medtech regulatory system
Regulators in Japan have offered more information on proposed changes to the country's system for regulating medical ...Learn More
Way beyond a watch: Sensor + app + bracelet combo is the future of wearables
Health monitoring devices of the future will not just be biometric tracking devices or journaling apps or detection and ...Learn More
Study shows promising results for Medtronic's pulmonary valve
A study presented at a recent cardiology meeting found that after a year, Medtronic's Melody transcatheter pulmonary valve ...Learn More
Bone graft substitutes from Zimmer to debut at Calif. meeting
Zimmer Spine plans to unveil its line of bone graft substitutes at a neurological surgeons conference in San Francisco, ...Learn More
Venaxis seeks FDA clearance for device to ID appendicitis risk
Venaxis has filed an application with the FDA seeking 510(k) clearance for its APPY1 Test, a blood-based assay designed to ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
Innovative medical devices help patients manage chronic disease
Advanced medical devices and diagnostics save lives, improve the quality of patient care and enhance productivity. ...Learn More
Giving opens the way for receiving.
Florence Scovel Shinn, American ...Learn More
Abbott gains FDA OK for device to treat blocked leg arteries
The FDA has granted Abbott premarket approval for the Supera stent, which it acquired through its $310 million purchase of ...Learn More
Pentagon extends supply contracts with Siemens, Hitachi
The Department of Defense has awarded a $1.79 billion contract extension to Siemens Medical Solutions and a $90.3 million ...Learn More
Medtech startups have access to early-stage funding in Mich.
Quantum Medical Concepts will invest as much as $250,000 a year in Michigan-based companies that are in the early stages of ...Learn More
Former Swiss-Tech exec joins Tegra as sales and marketing VP
Lee Crowe has been tapped to serve as vice president of sales and marketing at Tegra Medical. ...Learn More
Terumo to invest in R&D of French firm's bioresorbable heart stent
Arterial Remodeling Technologies, a French maker of a bioresorbable drug-eluting heart stent, has entered into a research ...Learn More
Medtronic's CoreValve system beats open-heart surgery in study
A study of patients considered to be at high risk of death during surgery found that those who received Medtronic's ...Learn More
Bacterin's bone graft yields positive results in arthrodesis study
A study in the journal Orthopedics found that patients who received foot and ankle arthrodesis using Bacterin's OsteoSponge ...Learn More
Herpes virus test from Quidel lands FDA clearance
The AmpliVue HSV 1+2 Assay, developed by Quidel, has received 510(k) clearance from the FDA. ...Learn More
FDA issues guidance on communicating medtech regulatory rule changes
The FDA's device center has issued guidelines on how it intends to notify companies of immediate changes in medical device ...Learn More
FDA issues updated list of devices subject to tracking rules
The FDA has released a document updating the list of devices that must be tracked under the final rule setting up a unique ...Learn More
Download new tool kit: Value of Medical Technology in Controlling and Treating Diabetes
Advances in medical technology are revolutionizing the ways in which millions of Americans live with diabetes, and in so ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
The older I grow, the more I distrust the familiar doctrine that age brings wisdom.
H.L. Mencken, American ...Learn More
Biotronik gains EU approval for advanced pacemakers
European regulators have given Biotronik the CE mark to market its Eluna pacemakers, designed to treat patients with ...Learn More
Stock sale pulls in $22.5M for Neovasc
Neovasc has obtained about $22.5 million through an offering of almost 4.2 million company shares valued at roughly $5.39 ...Learn More
Mo. drug-delivery device firm obtains $1.88M in fresh capital
A regulatory filing disclosed that Veran Medical Technologies has secured $1.88 million in additional financing. ...Learn More
Canada, Singapore OK IMDx's device to assess vancomycin resistance
IMDx has gained clearance in Canada and Singapore to market its VanR test, which runs on the Abbott m2000 molecular ...Learn More
Japan approves latest radiotherapy device from Accuray
Accuray has earned the green light to market its CyberKnife M6 system in Japan. ...Learn More
Ohio device firm offers rapid surgical sterilization device
Ohio-based Innovative Sterilization Technologies is marketing a device that allows for faster sterilization of surgical ...Learn More
First human trials of Reva's Fantom scaffold slated by year's end
Reva Medical plans to conduct the first human clinical studies of its Fantom bioresorbable scaffold by the end of the year ...Learn More
Meridian's device to detect B. pertussis bacteria gets FDA OK
The FDA has cleared Meridian Bioscience to market its Illumigene Pertussis assay, the fifth test that runs on the company's ...Learn More
Exact Sciences wins FDA panel support for colorectal cancer Dx test
An FDA panel has unanimously agreed to endorse premarket approval for Exact Sciences' Cologuard test, saying the assay is ...Learn More
Alimera Sciences again seeks FDA approval for eye implant
Alimera Sciences has for the fourth time filed an application with the FDA seeking marketing approval for its Iluvien eye ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Most people have to talk so they won't hear.
May Sarton, Belgian-American ...Learn More
Baxter to split into biopharma, medical-product companies
Baxter International said today that it would split into two companies: one for medical products and one for ...Learn More
Axonics obtains $32.6M to help fund neuromodulation device trials
A Series A funding round has pulled in $32.6 million for Axonics Modulation Technologies. ...Learn More
Vigilant Biosciences receives $2.3M boost for oral cancer test
Vigilant Biosciences has secured $2 million in a Series A funding round and a $300,000 loan from a Florida accelerator. ...Learn More
Fresenius rebrands renal-research business
Fresenius has changed the name of its renal-research division from the Clinical Studies Group at FMCNA to Frenova Renal ...Learn More
AdvaMed appoints Covidien CEO as new board chairman
Jose Almeida has been tapped to serve as chairman of AdvaMed's board, succeeding David Dvorak. ...Learn More
For more:
Read the AdvaMed press release about the group's new chairman, Jose ...Learn More
Report forecasts strong growth for global soft-tissue repair market
A Transparency Market Research report predicts that the global market for orthopedic soft-tissue repair devices will grow ...Learn More
French eye-device firm picks former Boston Scientific exec as CEO
Khalid Ishaque has been selected to be the new CEO of Pixium, a French company developing retinal implants. ...Learn More
The making of an icon: Dr. Tom Fogarty's obsession with innovation
Medtech icon Dr. ...Learn More
Cre8MDI seeks funds to advance arterial-stiffness assessment device
Cre8MDI is working on a sensor-based device that could allow for easier and less-expensive heart-disease diagnosis and ...Learn More
Trio of digital angiography devices from Shimadzu win FDA nod
The FDA has cleared Shimadzu Medical Systems to market its Trinias line of digital angiography devices. ...Learn More
Benefits of Epigenomics' colorectal cancer test outweigh risks, FDA panel says
A panel of FDA advisers has voted in favor of recommending the safety of Epigenomics' Epi proColon test, saying the ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Formal education will make you a living; self-education will make you a fortune.
Jim Rohn, American entrepreneur and motivational ...Learn More
Ariosa Diagnostics targets $69M in public offering
San Jose, Calif.-based Ariosa Diagnostics has filed for an initial public offering in an effort to obtain as much as $69 ...Learn More
Cernostics gets $100K boost for esophageal cancer test
Cernostics has secured $100,000 in financing from Ben Franklin Technology Partners of Northeastern Pennsylvania. ...Learn More
SurgiCor to offer Abyrx's bone putty across U.S.
Abyrx has entered into a distribution deal with SurgiCor to help bring its hemostatic bone putty products to orthopedic and ...Learn More
Report: Worldwide arthroscopic implants market poised for growth
A GlobalData report forecasts that the worldwide market for arthroscopic implants will be worth $3.4 billion by 2020. ...Learn More
Microfluidic device allows testing of anticoagulants
Researchers at the Georgia Institute of Technology have created a microfluidic device that could be used to evaluate the ...Learn More
Study shows promising results for BG Medicine's heart failure test
BG Medicine said its diagnostic heart failure test showed positive results in three global clinical trials involving 902 ...Learn More
Enhanced defibrillator lead from St. Jude is released
St. ...Learn More
Battery-powered device frees epilepsy patient from seizures
Kevin Ramsey, a 36-year-old patient with drug-resistant epilepsy, is now seizure-free after being implanted with a ...Learn More
FDA issues proposal to amend device-classification program
The FDA has released a proposed rule amending its process for classifying and reclassifying medical devices. ...Learn More
Quest Diagnostics unit gains FDA clearance for HSV test
The FDA has cleared Focus Diagnostics, a Quest Diagnostics unit, to market its Simplexa HSV 1&2 Direct assay, which runs on ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Don't look back. Something might be gaining on you.
Satchel Paige, American baseball ...Learn More
St. Jude Medical gains FDA approval for 3 heart devices
The FDA has granted St. ...Learn More
IPO could pull in as much as $76M for Corium
Corium International has filed for an initial public offering in hopes of obtaining as much as $76 million. ...Learn More
Stryker's purchase of Patient Safety Tech is finalized
Stryker has completed its acquisition of Patient Safety Technologies, which specializes in safety sponge devices, for ...Learn More
Funding round brings in $28M for Invendo Medical
Invendo Medical has obtained $28 million in financing, which the company said will go toward its U.S. ...Learn More
Partnership aims to develop CAD test after kidney transplant
Rosetta Genomics will work with Clalit Health Services' Rabin Medical Center-Beilinson Campus in Israel on a project to ...Learn More
Mazor signs second supply deal in Italy for Renaissance device
Mazor Robotics said it has secured a second order for its Renaissance guidance technology in Italy. ...Learn More
Vermillion's ovarian cancer test shows promising trial results
A study in the American Journal of Obstetrics & Gynecology found that using Vermillion's OVA1 assay in conjunction with ...Learn More
Benvenue releases device to treat vertebral compression fractures
Benvenue Medical said at a interventional radiology conference in San Diego that its Kiva VCF Treatment System, designed to ...Learn More
FDA guidance clarifies humanitarian-device exemption process
New guidance explaining the humanitarian-device exemption process for medical technologies used to treat rare conditions has ...Learn More
Upgraded device for noninvasive GERD treatment obtains FDA OK
The FDA has cleared Medigus to market its upgraded MUSE technology for use in patients with gastroesophageal reflux disease. ...Learn More
Innovative medical devices help patients manage chronic disease
Advanced medical devices and diagnostics save lives, improve the quality of patient care and enhance productivity. ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing had happened.
Winston Churchill, former British prime ...Learn More
XVIVO wins FDA panel vote for device to preserve donor lungs
A panel of FDA advisers has voted in favor of recommending humanitarian-use device exemption approval for XVIVO XPS ...Learn More
Shares offering could bring in as much as $150M for Foundation Medicine
Foundation Medicine has announced plans to conduct an offering of its stock worth as much as $150 million. ...Learn More
Calif. corneal implant maker targets up to $90M from IPO
California-based Presbia seeks to obtain as much as $90 million in an initial public offering. ...Learn More
Former Life Tech exec named director and chairman of Orthofix's board
Ronald Matricaria has been tapped to serve as a director and chairman of the board at orthopedic and spinal device firm ...Learn More
French molecular Dx firm plans to go public
Genomic Vision, maker of a molecular combing system designed to detect genetic disorders, has filed for an initial public ...Learn More
CMS to maintain reimbursement rate for Abiomed's heart pump
The CMS will maintain the same reimbursement rate for use of the Impella device when new rates take effect in the fall, ...Learn More
NCI awards $4.3M grant for genomic cancer drug research
Researchers at the University of Wisconsin Carbone Cancer Center and the Rutgers Cancer Institute of New Jersey will work ...Learn More
Latest radiation therapy device from ProTom gets FDA OK
The Radiance 330 Proton Therapy System has obtained clearance from the FDA, according to ProTom, which developed the ...Learn More
FDA seeks comments on 2 electrosurgical device proposals
The FDA has issued a pair of proposals outlining the requirements for manufacturers seeking 510(k) clearance for ...Learn More
Senator renews call to overturn medical device tax
Sen. ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Download new tool kit: Value of Medical Technology in Controlling and Treating Diabetes
Advances in medical technology are revolutionizing the ways in which millions of Americans live with diabetes, and in so ...Learn More
Service to others is the rent you pay for your room here on Earth.
Muhammad Ali, American ...Learn More
EKF Diagnostics continues acquisition trail
EKF Diagnostics has signed two separate deals to acquire DiaSpect Medical, a Sweden-based maker of hemoglobin analyzers, and ...Learn More
Venture capital firm seeks $137.7M for second biotech fund
Ysios Capital hopes to raise $137.7 million for its BioFund II, which it would invest in as many as 15 medical device, ...Learn More
Mass. esophageal imaging device maker NinePoint obtains $34M
A Series B funding round headed by Corning has brought in $34 million for NinePoint Medical. ...Learn More
Maker of bone graft collection device lands $350K investment
Avitus Orthopaedics has received an investment worth $350,000 from Connecticut Innovations. ...Learn More
St. Jude gains EU approval for advanced neurostimulator
St. ...Learn More
EU OKs robot-assisted surgery device from Medrobotics
European regulators have given Medrobotics the CE mark to market its robot-assisted surgery system for use during ...Learn More
Pentagon awards $234.3M in supply contracts to 3 medtech firms
The Department of Defense has awarded supply contracts worth a total of $234.3 million to Zimmer, Draeger and Altitude ...Learn More
Abiomed meets enrollment target for heart pump study
Abiomed has reached its goal of enrolling 30 patients in a clinical study of its Impella RP system, a cardiac pump designed ...Learn More
Mobile-based monitoring tool from HealthInterlink wins FDA nod
The FDA has cleared HealthInterlink to market its Beacon 2.0 remote patient monitoring software as a class II medical ...Learn More
FDA approves Cochlear's device to treat severe hearing loss
Australia-based Cochlear has secured FDA approval for its Nucleus Hybrid L24 Cochlear Implant System, designed to treat ...Learn More
Innovative medical devices help patients manage chronic disease
Advanced medical devices and diagnostics save lives, improve the quality of patient care and enhance productivity. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Education is the best provision for the journey to old age.
Aristotle, Greek ...Learn More
Sorin pays $20M for Oscor's cardiac leads business
Sorin has agreed to pay Oscor $20 million to acquire the latter's cardiac leads unit, including its production plant in the ...Learn More
Cancer molecular Dx firm could bring in $25M from IPO
Signal Genetics is looking to secure roughly $25 million in an initial public offering. ...Learn More
Calif. dry-eye device firm obtains about $16.6M
Oculeve, a spinoff of Stanford University, has raised more than $16.6 million in a round of financing from eight investors. ...Learn More
Startup developing Google Glass for doctors gets $3.2M boost
A round of venture capital financing from Emergence Capital Partners and DCM has brought in $3.2 million for Augmedix. ...Learn More
France to pilot incident report system for some devices
The French government has introduced a program requiring half-yearly reports be submitted by medical device manufacturers ...Learn More
Aurora debuts spinal fusion implant in Poland
Aurora Spine President and CEO Trent Northcutt said the company's ZIP ULTRA Minimally Invasive Interspinous Fusion system ...Learn More
DNA sequencing in a handheld laboratory -- Q&A with QuantuMDx founder Jonathan O'Halloran
QuantuMDx envisions a future where laboratory-quality diagnostics are mobile, cheap and available to everyone, from health ...Learn More
Late-stage study for Ocular Therapeutix's eye plug begins
Ocular Therapeutix has initiated a late-stage clinical study to test the use of its eye plug implant during cataract ...Learn More
Study compares CRC detection rate of stool DNA, FIT tests
A home-use stool DNA test detected 92.3% of colorectal cancers, compared with 73.8% found using fecal immunochemical test, ...Learn More
U.S. patent covering ACL graft issued to Tesa Medical
Tesa Medical said it has secured a U.S. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
The young always have the same problem -- how to rebel and conform at the same time. They have now solved this by defying their parents and copying one another.
Quentin Crisp, British ...Learn More
Digirad to pay up to $4.1M for heart monitoring service provider
Digirad has agreed to acquire heart monitoring service provider Telerhythmics for roughly $3.5 million in cash, plus ...Learn More
Financing round brings in $4M for Tyto Care
A round of financing from OrbiMed Israel and LionBird has pulled in $4 million for Tyto Care. ...Learn More
EU approves 3D hip arthroplasty planning tool from EOS
EOS imaging has obtained CE mark approval to market its hipEOS 3D hip arthroplasty planning tool in Europe. ...Learn More
$8.3M grant given to EU researchers for cardiovascular disease study
The European Commission has awarded a grant worth $8.3 million to a group of 30 scientists from 10 countries to study ...Learn More
EU post-approval study begins for St. Jude's leadless pacemaker
St. ...Learn More
FDA clears toe restoration device from Arthrosurface
The ToeMotion Total Toe Restoration System has obtained clearance from the FDA, according to Arthrosurface, which developed ...Learn More
Device to treat fractured proximal humerus gets FDA OK
The FDA has cleared Shoulder Options to market the AFT Proximal Humerus Fracture Plate. ...Learn More
Colo. hospital adopts Volpara's breast imaging system
Exempla Saint Joseph Hospital in Denver has deployed Volpara Solutions' VolparaDensity imaging system, which is used for ...Learn More
FDA asks for more data on Avedro's eye therapy system
The FDA has asked Avedro to submit additional data to support its new drug application for the KXL II cross-linking system. ...Learn More
AdvanDx seeks FDA clearance for MRSA test
AdvanDx has filed for FDA 510(k) clearance for its mecA XpressFISH test for detecting methicillin-resistant Staphylococcus ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
If more of us valued food and cheer and song above hoarded gold, it would be a merrier world.
J.R.R. Tolkien, British ...Learn More
Staar Surgical wins FDA panel vote for eye implant
An FDA panel has agreed to endorse the premarket approval application of Staar Surgical's Visian Toric Implantable Collamer ...Learn More
Itamar strikes sleep apnea device deal with Medtronic
Itamar Medical has entered into a distribution deal with Medtronic for undisclosed terms. ...Learn More
Olympus Biotech looks to sell production facility in N.H.
Olympus Biotech said it is seeking to find a company to acquire its manufacturing facility in Lebanon, N.H., by the end of ...Learn More
Hologic reorganizes top tier
Glenn Muir has stepped down as chief financial officer at women's health device firm Hologic, while Eric Compton, a former ...Learn More
Natera moves to bring prenatal test to Thailand, Portugal
Natera has struck two marketing deals for its Panorama prenatal test, designed for the noninvasive detection of trisomy 13, ...Learn More
Xeltis wraps up trial enrollment for biodegradable scaffold
Xeltis said it has concluded enrollment in a small feasibility trial evaluating the use of its biodegradable scaffold in ...Learn More
Report: Sleep disorder Dx market could hit $125.8M by 2017
A Frost & Sullivan report predicts that the market for devices used to diagnose sleep disorders, such as clinical and ...Learn More
Cruciate-retaining knee device released by Smith & Nephew
Smith & Nephew said its JOURNEY II Cruciate Retaining system, which is based on the company's VERILAST technology, is now ...Learn More
3D-printed tracheal splint lets toddler with rare condition go home
Eighteen-month-old Garrett Peterson was born with tracheobronchomalacia, a condition in which even the slightest movement ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Download new tool kit: Value of Medical Technology in Controlling and Treating Diabetes
Advances in medical technology are revolutionizing the ways in which millions of Americans live with diabetes, and in so ...Learn More
Rare as is true love, true friendship is rarer.
Jean de La Fontaine, French writer and ...Learn More
IPO could bring in as much as $100M for K2M
K2M, a maker of implantable spinal devices designed for hospital use, is looking to obtain as much as $100 million in an ...Learn More
$7.5M financing round for BiO2 Medical advances
A funding round aiming for $7.5 million has brought in almost $5.9 million for BiO2 Medical. ...Learn More
Calif. molecular Dx company raises $1.25M in funding round
California-based QuanDx has obtained $1.25 million in a Series B round of financing from undisclosed backers. ...Learn More
Former Life Tech exec joins DJO Global as CFO
Susan Crawford has been tapped to serve as chief financial officer at DJO Global. ...Learn More
EU approves Boston Scientific's MRI-safe pacemaker leads
European regulators have given Boston Scientific the CE mark to market its Ingevity suite of pacemaker leads. ...Learn More
Strong growth expected for EU motion-preserving spinal market
A recent report from Medtech Insight predicts the market for non-fusion, motion-preserving spinal systems in Europe will ...Learn More
Biotronik gains FDA approval to expand ProMRI study
The FDA has granted Biotronik the green light to conduct a phase III study of its ProMRI system. ...Learn More
Bacterin introduces novel allograft for orthopedic procedures
Bacterin said its allograft tailored for use in orthopedic surgery is available commercially. ...Learn More
Hamburg: FDA is on par with other countries in terms of device review times
The FDA has reduced its applications backlog for lower-risk devices by 27% and higher-risk devices by 43% since fiscal year ...Learn More
Siemens exec calls for prompt bipartisan action on device tax repeal
Siemens Healthcare North America employs more than 3,600 workers in North Carolina, but the 2.3% medical device tax has ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Innovative medical devices help patients manage chronic disease
Advanced medical devices and diagnostics save lives, improve the quality of patient care and enhance productivity. ...Learn More
In the spring, at the end of the day, you should smell like dirt.
Margaret Atwood, Canadian ...Learn More
Boston Scientific's bare-metal coronary stent wins EU approval
European regulators have granted Boston Scientific CE mark approval to market its Rebel system, a bare-metal stent designed ...Learn More
Investment group seeks $200M for second health care fund
A regulatory filing indicates that Venrock Healthcare Capital Partners, which invests in biotech and health IT firms, is ...Learn More
Pa. drug delivery device firm secures $60M loan
Unilife, a York County, Pa.-based maker of drug delivery devices, has obtained $60 million in debt financing from OrbiMed ...Learn More
Ariosa earns reimbursement code for prenatal test
Ariosa Diagnostics has received a Category 1 MAAA CPT code for its Harmony Prenatal Test. ...Learn More
EU approves antimicrobial spine implant from DiFusion
DiFusion Technologies has earned the CE mark to market its CleanFuze system in Europe. ...Learn More
Runners with medical devices invited to join Medtronic marathon
Medtronic is seeking as many as 25 runners who use pacemakers and certain other medical devices to participate in the ...Learn More
Integra debuts laminoplasty device in U.S.
The Integra Laminoplasty System has been implanted for the first time in the U.S. ...Learn More
Surgical device to detect peripheral nerve damage gets FDA OK
The FDA has cleared SafeOp Surgical to market the EPAD neuromonitoring technology, which the company acquired from Impulse ...Learn More
Panel backs use of Roche's HPV test as first-line cancer screening tool
An FDA panel has unanimously agreed to recommend the use of Roche's cobas HPV assay as a first-line cervical cancer ...Learn More
FDA clears image processing tool from Halifax Biomedical
Halifax Biomedical has been cleared by the FDA to market its image processing technology. ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Nature uses as little as possible of anything.
Johannes Kepler, German mathematician and ...Learn More
EKF, Quest Diagnostics announce acquisition deals
EKF Diagnostics hopes to widen its footprint in the hematology testing market with its $4 million purchase of Separation ...Learn More
Accellent wraps up $390M purchase of Lake Region Medical
Accellent has completed its acquisition of Lake Region Medical, which supplies pacemaker lead wires to Medtronic, for about ...Learn More
Stock sale could pull in about $24.5M for iCAD
ICAD hopes to raise net proceeds of about $24.5 million in a shares offering. ...Learn More
N.J. interventional cardiology device firm obtains $5M
Svelte Medical has received $5 million in fresh capital from the West Health Investment Fund, bringing the company's total ...Learn More
3 industry groups in Brazil sign MOU with AdvaMed on ethics code
A memorandum of understanding has been signed by AdvaMed and three medtech industry groups in Brazil to bring that country's ...Learn More
For more:
Read the AdvaMed press release about signing the MOU with Brazil's medtech ...Learn More
Breathing easier with SinuSys
SinuSys CEO Thomas Schreck and CMO Dr. ...Learn More
Medicare contractor agrees to cover Si-Bone's spinal fusion system
An earlier noncoverage decision for Si-Bone's iFuse spinal fusion system has been reversed by Medicare contractor Palmetto ...Learn More
Bone graft systems from RTI Surgical debut at La. meeting
RTI Surgical is introducing a pair of its bone graft products at an orthopedic surgery meeting this week in New Orleans. ...Learn More
CT myocardial perfusion tool from Toshiba gets FDA OK
The FDA has cleared Toshiba America Medical Systems to market its myocardial perfusion software, which will be available on ...Learn More
FDA finalizes guidelines on CLIA process for in vitro diagnostics
The FDA has issued final guidelines addressing compliance with the agency's Clinical Laboratory Improvement Amendments ...Learn More
AngioDynamics' venous drainage device gets extended-use clearance from FDA
The FDA has granted AngioDynamics expanded clearance for its AngioVac venous drainage device, designed to help eliminate ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
The single biggest problem in communication is the illusion that it has taken place.
George Bernard Shaw, Irish ...Learn More
Lombard Medical targets up to $80M from IPO
Lombard Medical, which develops aneurysm repair devices, seeks to obtain as much as $80 million in an initial public ...Learn More
Stryker wraps up Pivot Medical acquisition
The purchase of hip arthroscopy device firm Pivot Medical by Stryker has been finalized. ...Learn More
Funding round brings in $27M for Exosome Diagnostics
A Series B funding round has pulled in $27 million for Exosome Diagnostics. ...Learn More
OrbusNeich begins stent trial ahead of Japanese approval bid
OrbusNeich has begun patient enrollment in a clinical study in Japan and the U.S. ...Learn More
EU research program aims to create sepsis detection device
European scientists have launched a program to create an assay based on colorimetric detection technology that can be used ...Learn More
Device to help prevent HAIs is in the offing
Aerobiotix is working on a device, called the Aero One, which uses ultraviolet light to target spores, bacteria, viruses and ...Learn More
2 orthopedic devices from Ellipse land FDA clearance
Ellipse Technologies has been cleared by the FDA to market its Magec system, which is used for the treatment of early onset ...Learn More
Knee device from Maxx Orthopedics wins FDA nod
The FDA has cleared Maxx Orthopedics to market its Freedom PCK Components system. ...Learn More
Cephaly gains FDA approval for device to prevent migraines
The FDA has granted Cephaly Technology approval to market its Cefaly system for use as a preventive treatment for migraines. ...Learn More
FDA agrees to allow Wright to amend PMA for bone graft
The FDA's Office of Device Evaluation has agreed to allow Wright Medical to amend its premarket approval application for the ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
He who stops being better stops being good.
Oliver Cromwell, British military ...Learn More
TriVascular plans to go public to raise $100M
TriVascular Technologies, which develops abdominal aortic aneurysm repair devices, has filed for an initial public offering ...Learn More
Quest closes Solstas Lab Partners acquisition
The $570 million acquisition of Solstas Lab Partners by Quest Diagnostics has been finalized. ...Learn More
Utah firm developing soft-tissue cutting device obtains $11.6M
A group of 10 undisclosed backers has pumped $11.6 million into Domain Surgical. ...Learn More
Smith & Nephew strikes marketing deal with OrthoSensor
Smith & Nephew has agreed to market its LEGION and JOURNEY II Total Knee Systems in combination with the VERASENSE ...Learn More
IPO could pull in up to $75M for Scottish transfusion Dx firm
Quotient seeks to obtain as much as $75 million in an initial public offering. ...Learn More
Argentina authorizes sale of Epigenomics' colorectal cancer test
ANMAT, Argentina's diagnostic test regulatory agency, has given VSA Alta Complejidad the go-ahead to distribute the Epi ...Learn More
Firm wins approval to launch pain device trials in Australia
Mainstay Medical has received the go-ahead in Australia to conduct clinical studies of its ReActiv8 system, an implantable ...Learn More
New model of Cardiovascular Systems' PAD device gets FDA OK
The FDA has cleared Cardiovascular Systems to market a 60-centimeter, 4 French version of its Diamondback 360 system, an ...Learn More
FDA discontinues notarization of medtech export documents
The FDA said in a notice that it has stopped notarizing medtech export certificates, effective March 1. ...Learn More
Review date for EnteroMedics' obesity device pushed back by FDA
An FDA panel scheduled to review EnteroMedics' premarket approval application for the Maestro VBLOC system has been ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
We must indeed all hang together, or most assuredly, we shall all hang separately.
Benjamin Franklin, American statesman and Founding ...Learn More
IPO could bring in as much as $100M for Biomet
Biomet, which specializes in artificial knees and hip joints, seeks to obtain as much as $100 million in an initial public ...Learn More
Brainsway receives about $11.8M in financing
Yelin Lapidot Investment House has pumped about $11.8 million into Brainsway. ...Learn More
Former IMDS exec named president of DJO Surgical
Brady Shirley has been tapped to serve as president at DJO Surgical, according to orthopedic device firm DJO Global. ...Learn More
Incubator works to foster medtech, diagnostic startup growth in India
InnAccel has created a six-month fellowship program in India to train designers and engineers to promote development of ...Learn More
3 U.K. patients first to receive Edwards' mitral valve implant
Three patients at St. ...Learn More
LDR achieves milestone for VerteBRIDGE technology
More than 50,000 patients across the globe have been implanted with the VerteBRIDGE plating system, according to LDR, a ...Learn More
Device to help treat tinnitus set to undergo clinical trials
MicroTransponder, a University of Texas at Dallas spinoff, is preparing to conduct clinical studies of its Serenity System ...Learn More
Heart attack patient finds new hope in implantable defibrillator
Gary Couse, who has been tied to an external defibrillator since suffering cardiac arrest three months ago, has new hope ...Learn More
FDA clears AngioDynamics' hemodialysis catheter
The FDA has cleared AngioDynamics to sell its BioFlo DuraMax system, which the company said could hit the market during its ...Learn More
Pluristem gains FDA OK for new manufacturing plant in Israel
The FDA has granted Pluristem Therapeutics approval to use its new manufacturing plant in Haifa, Israel, allowing it to take ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
I never think of the future. It comes soon enough.
Albert Einstein, German-born theoretical ...Learn More
Slovenian medtech firm bought by Gores and Technology4Medicine
Fotona, a Slovenia-based company that develops medical lasers, has been acquired by investment firm Gores and its partner ...Learn More
Mass. imaging device firm adds $560K to its coffers
Lumicell Diagnostics, which recently completed a $1 million funding round, has received $560,000 in additional financing. ...Learn More
Ovarian cancer test drives Q4 revenue growth for Vermillion
Vermillion generated $1.6 million in revenues during the fourth quarter of 2013, an increase from $1.1 million during the ...Learn More
Partnership aims to create investment opportunities for medtech
Medical device incubator Proception Medical said it has forged a collaboration with an undisclosed private equity group, ...Learn More
EU approves MR-compatible cardiac leads from Biotronik
Biotronik has earned the CE mark in Europe for its bipolar cardiac resynchronization therapy leads with a 1.6-millimeter ...Learn More
Updated EU standards for medical devices arriving soon
A series of EU medtech requirements will be replaced by updated standards over the next several months, including for ...Learn More
Firm reports positive trial results for respiratory monitor
A clinical study found that Respiratory Motion's ExSpiron system, designed for noninvasive respiratory monitoring, proved ...Learn More
Advanced knee surgery tool from Exactech to debut at conference
Exactech plans to unveil its ExactechGPS Guided Personalized Surgery tool at a forthcoming orthopedic conference in New ...Learn More
MedShape's suture anchor device gains FDA clearance
The FDA has given MedShape 510(k) clearance to market its Morphix SP Suture Anchor system. ...Learn More
FDA labels GE's neonatal devices recall as Class I
A recall initiated by GE Healthcare involving some of its Giraffe and Panda neonatal infant warmers and resuscitation ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Opportunity is sometimes hard to recognize if you're only looking for a lucky break.
Monta Crane, ...Learn More
Biotech sector saw strong M&A activity in Q4, report says
A PricewaterhouseCoopers report finds that although the number of mergers and acquisitions in the medtech sector dropped by ...Learn More
Immunexpress gets $6M boost to promote sepsis diagnostics
Immunexpress has obtained $6 million in a funding round headed by the Debiopharm Group in Switzerland. ...Learn More
Funding round pulls in $3.3M for N.Y. genetic testing startup
A Series A funding round led by FirstMark Capital has brought in $3.3 million for Recombine. ...Learn More
Foundation unveils startup focused on drug-delivery devices
A medical device startup known as Medallion Therapeutics is being launched by the Alfred Mann Foundation. ...Learn More
EU approves Biodesix's lung cancer diagnostic test
Biodesix has earned the CE mark to market its VeriStrat sample-collection kit. ...Learn More
Report: Worldwide biomaterials market could hit $88.4B in 3 years
A report from MarketsandMarkets predicts that the worldwide biomaterials market will grow from $44 billion two years ago to ...Learn More
Medtech trends: The most talked-about device makers in February 2014
MassDevice.com looks at the Internet chatter surrounding the medical device industry with some of most searched-for ...Learn More
Ortho achieves milestone for motion analysis technology
More than 1,000 patients have been tested using the Vertebral Motion Analysis tool, according to Ortho Kinematics, which ...Learn More
Google Glass tool created to aid interpretation of test strips
University of California, Los Angeles, researchers have created a Google Glass app designed to assist with interpretation of ...Learn More
Siemens reports first U.S. installation of advanced mammo device
The Pink Breast Center in New Jersey has installed Siemens Healthcare's Mammomat Inspiration Prime Edition system, the first ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Watch new video on value of life-changing medical technology
Medical technology has revolutionized the treatment and care of patients while decreasing overall health system costs and ...Learn More
Why not go out on a limb? Isn't that where the fruit is?
Frank Scully, American ...Learn More
Staar Surgical achieves regulatory milestones for eye implant
An FDA panel meeting originally set for Feb. ...Learn More
Calif. surgery device maker obtains $36M in Series E financing
A Series E funding round headed by HealthCare Royalty Partners has pulled in $36 million for Invuity. ...Learn More
BioTrace Medical nears $3.5M funding goal
California-based BioTrace Medical has obtained more than $3.4 million in a funding round aiming for $3.5 million. ...Learn More
Sites Medical's expansion plan could create 45 new jobs in Ind.
Sites Medical has announced plans to lease an 8,000-square-foot space in Columbia City, Ind., as the medtech company ...Learn More
Nanotronics adds MetaMed co-founder to advisory board
Nanotronics Imaging, which specializes in optical microscopy technology for life sciences, biotechnology and health care ...Learn More
Israeli biotech firms announce IPO, shares offering
Israel-based MediWound, a unit of Clal Biotechnology and maker of the NexoBrid product designed to treat burns faster than ...Learn More
Firm gains funds to help finance U.S. trial of prostate device
A Series C funding round initially targeted at $18 million has brought in $20 million for NxThera. ...Learn More
Intellirod raises $1.6M to advance spinal implants to market
The Ohio Third Frontier's Commercial Acceleration Loan Fund has provided $1.6 million in debt financing to Intellirod Spine. ...Learn More
AstraZeneca obtains FDA nod for Bydureon pen
The FDA has granted AstraZeneca approval for its Bydureon pen, 2 milligrams, to help bolster glucose control in adult type 2 ...Learn More
FDA seeks comments on off-label use data distribution proposal
The FDA will accept comments through May 2 on its draft guidance governing the dissemination of data on off-label uses of ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Download new tool kit: Value of Total Joint Replacement for People with Osteoarthritis
Total joint replacement is a valuable treatment option for many of the 27 million Americans who suffer from osteoarthritis, ...Learn More
The only thing that ever sat its way to success was a hen.
Sarah Brown, American ...Learn More
Medtronic-backed EarLens nears $38.8M financing target
California-based EarLens has received $36 million from 22 undisclosed backers, bringing the company closer to its $38.8 ...Learn More
Myriad's $245M purchase of Crescendo Bio is finalized
Myriad Genetics has wrapped up its purchase of Crescendo Bioscience for $245 million. ...Learn More
Lumenis secures $75M from IPO; Microlin seeks to raise $25M
Lumenis, an Israeli maker of laser devices designed for ophthalmic, surgical and aesthetic uses, has raised $75 million in ...Learn More
Mass. maker of hemodynamic monitor adds $9M to its coffers
Massachusetts-based Cheetah Medical has raised $9 million in financing, which President and CEO Chris Hutchison said will go ...Learn More
Global investment group raises $375M in 10th biotech fund
Abingworth has raised $375 million for its 10th fund aimed at companies in the life sciences sector. ...Learn More
Lima agrees to offer OrthAlign's knee device on French market
Lima France has struck a deal with OrthAlign to offer the latter's KneeAlign system on the French market. ...Learn More
Hospital network awards supply contracts to Medtronic, Abbott
SharedClarity, a joint venture formed by UnitedHealthcare and Dignity Health in 2012 to lower the costs of medical devices ...Learn More
PGA Tour taps Stryker as joint replacement device supplier
Stryker has entered into a marketing partnership with the PGA Tour for undisclosed terms. ...Learn More
3D-printed device could aid in treating heart rhythm disorders
U.S. ...Learn More
FDA labels Medline's guidewire recall as Class I
A recall initiated by Medline Industries involving certain lots of its ACME Monaco guidewires, which are used to aid ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Download new tool kit: Value of Total Joint Replacement for People with Osteoarthritis
Total joint replacement is a valuable treatment option for many of the 27 million Americans who suffer from osteoarthritis, ...Learn More
The discovery of a new dish does more for human happiness than the discovery of a new star.
Jean Anthelme Brillat-Savarin, French lawyer and ...Learn More
ResMed to repurchase up to 20M company shares
ResMed, which develops sleep apnea devices, plans to repurchase as many as 20 million shares of its stock on an ongoing ...Learn More
Boston Scientific moves to bolster presence in emerging markets
Boston Scientific is taking steps to increase its medical device sales in emerging markets such as India, China, Latin ...Learn More
Calif. maker of cord blood processing products gets $2.5M boost
SynGen has secured $2.5 million in debt financing from GE Capital, Healthcare Financial Services. ...Learn More
Carlyle picks former Millipore exec to lead Ortho-Clinical
The Carlyle Group has appointed Martin Madaus, the former president and CEO of Millipore, to serve as chairman and CEO of ...Learn More
Report: Worldwide medical electrode market poised for growth
A report from Global Industry Analysts forecasts that the global market for medical device electrodes could be worth $1.9 ...Learn More
Varian Medical strikes supply deal in Myanmar
Varian Medical Systems has signed a deal to supply Yangon General Hospital in Myanmar with its linear accelerator and ...Learn More
Va. hospital recruits participants in heart failure device study
Norfolk, Va.-based Sentara Heart Hospital is enrolling congestive heart failure patients in a national study evaluating the ...Learn More
Device to treat infection after knee surgery wins FDA nod
The FDA has cleared Ortho Development to market its KASM Knee Articulating Spacer Mold system. ...Learn More
FDA seeks to retain existing rules on 510(k) device modifications
A new FDA proposal governing its review of 510(k) medical device modifications would clarify and add to existing policy ...Learn More
Proposal to revoke device tax heads to Senate Finance Committee
A proposal to strike down the roughly $30 billion medical device tax included in the health care law has been forwarded to ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Always tell the truth. You may make a hole in one when you're alone on the golf course someday.
Franklin P. Jones, American ...Learn More
Covidien gains FDA OK for ventilator with smart pumping system
Covidien has secured FDA clearance to market its Puritan Bennett 980 Ventilator for use in adults, children and neonatal ...Learn More
Covidien wraps up $860M purchase of Given Imaging
The acquisition of Given Imaging by Covidien for roughly $860 million has been finalized. ...Learn More
Prenatal test drives Q4 revenue growth for Sequenom
San Diego firm Sequenom posted $45.1 million in revenues for the fourth quarter of 2013, a 34% increase from the same period ...Learn More
Metamark secures license for clinical lab in Mass.
The state of Massachusetts has granted a license to Metamark Genetics' Cambridge, Mass., clinical laboratory. ...Learn More
U.K. maker of blood analyzer appoints new CEO
Wolfgang Rencken, the former chief executive of Maquet Cardiovascular, has been tapped to replace Stuart Hendry as CEO of ...Learn More
Devices to detect ovarian cancer, infertility are in the works
NVision Medical is developing two diagnostic devices that could be used in doctors' offices: a catheter-based, pap ...Learn More
EDGE's compression screws OK'd by FDA for foot and ankle procedures
EDGE Orthopaedics has been cleared by the FDA to market its BITE Compression Screws for use in foot and ankle surgeries. ...Learn More
Chimaera imaging tool for Aycan workstation wins FDA nod
The FDA has cleared Chimaera to market its FusionSync software, designed to enhance management and analysis of multimodality ...Learn More
Tax reform proposal includes device tax repeal
House Ways and Means Committee Chairman Dave Camp, R-Mich., has introduced a tax reform package that would strike down the ...Learn More
For more:
Read a statement from AdvaMed commending Rep. ...Learn More
E-system for requesting medtech export documents updated by FDA
Updates have been made by the FDA's device center to its voluntary electronic system designed to allow medtech companies to ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Clarity is the counterbalance of profound thoughts.
Luc de Clapiers, French ...Learn More
Reverse Medical's neurovascular device gains approval in Europe
Reverse Medical has earned the CE mark to market its UNO neurovascular embolization device in Europe and hopes to release ...Learn More
ConMed reaches deal with stakeholder on board shuffle
ConMed has announced that it would increase the number of its board members from nine to 11 as part of a deal reached with ...Learn More
Zimmer renews supply contract with Pioneer Surgical
Zimmer has agreed to renew its supply contract with Pioneer Surgical Technology, a unit of RTI Surgical. ...Learn More
China adopts new medtech regulations
China's State Council adopted new and updated medical device regulations that the China Food and Drug Administration says ...Learn More
EU approves Ellex Medical's laser device to treat AMD
European regulators have granted Ellex Medical Lasers CE mark approval for its Retinal Rejuvenation Therapy laser system. ...Learn More
Ocular Therapeutix's eye plugs obtain reimbursement code
The American Medical Association has released a reimbursement code for Ocular Therapeutix's drug-eluting eye plugs. ...Learn More
Group works to lure Janssen Labs for Houston biomedical hub
Texas Medical Center President Robert Robbins said the center is in discussions with Janssen Labs, an external arm of ...Learn More
Cook announces U.S. release of lung cancer detection device
Cook Medical said its EchoTip ProCore HD Endobronchial Ultrasound Biopsy Needle is commercially available in the U.S. ...Learn More
Device tax could threaten Ind.'s medtech jobs, senator says
The medical device tax has caused medtech companies to lay off workers and delay research and development projects since it ...Learn More
AdvaMed supports India's proposal to separate device, drug regulation
A bill proposed in India that would recognize medical devices as different from drugs for regulatory purposes has earned ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Download new tool kit: Value of Total Joint Replacement for People with Osteoarthritis
Total joint replacement is a valuable treatment option for many of the 27 million Americans who suffer from osteoarthritis, ...Learn More
No man was ever wise by chance.
Seneca, Roman ...Learn More
J&J unit gets FDA OK for device to treat atrial fibrillation
Biosense Webster, a Johnson & Johnson unit, has received premarket approval from the FDA for its force-sensing ablation ...Learn More
Teva's $144M purchase of NuPathe is finalized
Teva Pharmaceutical Industries has finalized its acquisition of NuPathe for $144 million. ...Learn More
Former Sangart exec joins Integra as chief scientific officer
Kenneth Burhop has been appointed to serve as chief scientific officer and corporate vice president at Integra LifeSciences. ...Learn More
Draft form for applicant notified bodies in EU issued
The European Commission's Notified Body Operations Group has published a draft application form that notified bodies can use ...Learn More
Insurer partners with Medtronic on congestive heart failure study
Aetna is working with Medtronic to evaluate patients with congestive heart failure using medical device data, Aetna CEO Mark ...Learn More
2 patients in Kan. receive Abiomed's implantable heart pump
Two patients with advanced heart failure at the Kansas Medical Center in Andover were implanted with the Impella heart pump ...Learn More
Barco releases clinical monitor for consistent image viewing
Barco has announced the launch of its Eonis 24 monitor, designed for use in semi-sterile and hospital settings. ...Learn More
Patients with single-sided deafness gain new hope with novel device
Keith LeBlanc, the parts manager for a Nissan dealership, and Stuart Hampton, a musician, both have single-sided deafness, ...Learn More
Freeze-dried genetic test kits from Biofortuna get FDA clearance
The FDA has cleared Biofortuna to market its freeze-dried SSPGo HLA PCR kits, designed for use in transplantation genotyping ...Learn More
FDA widens clearance for Verizon's patient monitoring tool
The FDA has granted Verizon expanded clearance for its Converged Health Management platform, which monitors and sends ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
Watch new video on value of life-changing medical technology
Medical technology has revolutionized the treatment and care of patients while decreasing overall health system costs and ...Learn More
Fortune knocks but once, but misfortune has much more patience.
Laurence Peter, Canadian ...Learn More
SQI gains approval for celiac disease test in Canada
SQI Diagnostics has received the go-ahead in Canada to market its Ig_plex Celiac DGP Panel for clinical lab use. ...Learn More
Calif. vascular imaging device firm receives $5M funding boost
California-based Evena Medical has obtained $5 million in Series B financing with a goal of $15 million. ...Learn More
Minn. maker of infection-fighting catheter closes about $1.6M round
Pursuit Vascular, a Maple Grove, Minn.-based startup that won FDA clearance for its ClearGuard HD device in December, has ...Learn More
Former Medtronic exec named marketing director at VEXIM
Sandrine Carle has been tapped to serve as marketing director for VEXIM, a maker of devices to treat vertebral fractures and ...Learn More
EU approves West's device used in intradermal injections
West Pharmaceutical has received CE mark approval to market its Intradermal Adapter in Europe. ...Learn More
Metabolon strikes research, licensing deals for diabetes tech
Metabolon has agreed to allow Patia Biopharma to exclusively license its prediabetes test for insulin resistance assessment ...Learn More
NCI backs kidney cancer companion Dx test development
The National Cancer Institute has awarded 20/20 GeneSystems a contract worth $750,000 under the Phase II Small Business ...Learn More
Masimo makes pulse oximeter app available for Android smartphones
Masimo has announced that it is releasing a model of its iSpO2 pulse oximeter that can be used with Android smartphone ...Learn More
Obama urged to support repeal of device tax
Ahead of a visit by President Barack Obama to the Twin Cities, Rep. ...Learn More
Lower regulatory bar for certain iontophoresis devices proposed
A panel of FDA advisers has proposed that the agency downgrade iontophoresis systems designed for local drug delivery, ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
None who have always been free can understand the terrible fascinating power of the hope of freedom to those who are not free.
Pearl S. Buck, American ...Learn More
Medtronic plans to sell $2B in senior debt notes
Medtronic has announced that it will sell senior debt notes worth a total of $2 billion, which are due in 2017, 2024 and ...Learn More
Debt funding round pulls in $75M for Paradigm Spine
Spinal implant maker Paradigm Spine has secured $75 million in debt financing from PDL BioPharma. ...Learn More
Texas' Seno breast imaging device firm advances $39M funding round
Texas-based Seno Medical Instruments has obtained $30.4 million in a funding round that aimed for $39 million. ...Learn More
Novita creates 2 spinoff medical device companies
Novita Therapeutics is closing its doors after spinning off two medtech companies, Metactive Medical and Flow Forward ...Learn More
J&J unit wins approval for renal denervation device in Europe
Cordis, a unit of Johnson & Johnson, has received CE mark approval to market its Renlane Renal Denervation Catheter in ...Learn More
Report: Global fracture repair market could hit $2.82B in 5 years
A report from Transparency Market Research forecasts that the global market for minimally invasive vertebral compression ...Learn More
Partnership aims to develop test bed for medical sensors
Samsung has partnered with the University of California, San Francisco, to create a platform for testing medical sensors and ...Learn More
Philips prepares to roll out automated drug-dispensing system
Philips is preparing to launch its Medido system in the Netherlands, Belgium and Luxembourg. ...Learn More
FDA issues guidelines for obtaining feedback on device submissions
New guidance released by the FDA outlines the agency's revised process for requesting regulators' feedback on premarket ...Learn More
Exact Sciences anticipates positive FDA decision over Cologuard
Exact Sciences said it has earned CLIA certification for its internal laboratory, which comes as the company awaits FDA ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Democracy is the recurrent suspicion that more than half of the people are right more than half of the time.
E.B. White, American ...Learn More
Stryker moves to expand footprint in sports medicine market
Stryker has agreed to pay an undisclosed sum to purchase Pivot Medical, along with its hip arthroplasty technology. ...Learn More
Analysis IDs major trends shaping medtech industry
Mergers and acquisitions within the medical device industry remained steady last year, despite a drop in medtech ...Learn More
Funding round pulls in $40.7M for health care VC firm
NaviMed Partners, which invests in health care companies, has secured $40.7 million from five undisclosed backers. ...Learn More
Ariz. orthopedic device firm obtains $5M in financing
Arizona-based Cayenne Medical has raised $5 million from nine investors, bringing the company closer to its $6 million ...Learn More
Md. startup developing brain microchip hopes to raise $1.5M
Diagnostic Biochips is looking to obtain $1.5 million in angel financing, which the company would use to support marketing ...Learn More
Stock sale brings in $11.49M for Canadian surgical robotics firm
A public stock sale has pulled in $11.49 million for Titan Medical. ...Learn More
Aurora's spinal surgery device debuts in U.K.
Aurora Spine has introduced its ZIP Ultra Interspinous Fusion System in the U.K. ...Learn More
Medtronic reports first U.S. implant of tiny pacemaker
Medtronic said its Micra Transcatheter Pacing System has been implanted for the first time in the U.S. ...Learn More
IMRIS launches MRI-safe and CT-compatible surgical headrest
IMRIS has announced the launch of its horseshoe headrest designed for use during neurological procedures. ...Learn More
Inspire Medical wins FDA panel vote for sleep apnea device
An FDA panel reportedly agreed Thursday to endorse Inspire Medical's Inspire II Upper Airway Stimulator for marketing ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Download new tool kit: Value of Total Joint Replacement for People with Osteoarthritis
Total joint replacement is a valuable treatment option for many of the 27 million Americans who suffer from osteoarthritis, ...Learn More
If you hear a voice within you say, 'You cannot paint,' then by all means paint, and that voice will be silenced.
Vincent Van Gogh, Dutch ...Learn More
Medtronic wins U.S., EU approvals for tiny heart monitor
Medtronic has secured approval in Europe and the U.S. ...Learn More
Philips, SonoCine strike breast ultrasound distribution deal
Philips Healthcare will market its iU22 and Epiq ultrasound scanners in combination with SonoCine's automated whole-breast ...Learn More
Mass. center awards $25M in tax incentives to 33 biotech firms
A group of 33 biotech companies, including those focused on medical devices and diagnostics, will receive tax incentives ...Learn More
Pa. insurer agrees to cover Uroplasty's overactive bladder device
Independence Blue Cross in southeast Pennsylvania has agreed to provide up to two years of reimbursement coverage for ...Learn More
Zynex gains clearance for rehabilitation devices in Russia
Regulators in Russia have granted Zynex marketing clearance for its NexWave and NeuroMove systems. ...Learn More
Singapore military awards AED supply contract to HeartSine
The Singapore Ministry of Defense has awarded HeartSine Technologies a multimillion-dollar contract to supply its armed ...Learn More
Centogene sells Canadian genetic testing unit to LifeLabs
LifeLabs Medical Laboratory Services has agreed to pay an undisclosed sum to purchase the Canadian subsidiary of German firm ...Learn More
Dr. Tom Fogarty: My balloon catheter wouldn't survive today's FDA
Medtech legend and founder of the Fogarty Institute for Innovation Dr. ...Learn More
Firms partner to develop companion Dx for leukemia drug
MolecularMD has entered into a development deal with Novartis for undisclosed terms. ...Learn More
Trial underway for AUM's coronary artery disease Dx tool
AUM Cardiovascular is conducting a clinical study of its Cadence system to demonstrate that the device is just as effective ...Learn More
FDA panel review of Inspire's sleep apnea device slated today
A panel of FDA advisers is set to meet today to consider whether Inspire Medical Systems' Inspire II Upper Airway Stimulator ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...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, American ...Learn More
AdvaMed survey finds about 165K jobs compromised due to device tax
The $30 billion medical device tax has resulted in about 14,000 job cuts, deferred hiring of 19,000 workers and indirectly ...Learn More
For more:
Read the AdvaMed survey report to learn more about the real-world impact of the medical device tax in the year since it took ...Learn More
Stryker boosts operating-room-device portfolio with Berchtold buy
Stryker has agreed to pay $172 million to acquire Berchtold Holding, a German maker of surgical-room equipment. ...Learn More
Direct Flow Medical gets $50M boost to advance TAVI device
A debt funding round has brought in $50 million for Direct Flow Medical. ...Learn More
Investors pump $37.5M into Alimera Sciences
Georgia-based Alimera Sciences has obtained $37.5 million in financing from 21 undisclosed backers, which would go toward ...Learn More
EU widens approval for Boston Scientific's esophageal stent
European regulators have granted Boston Scientific expanded CE mark approval for its WallFlex stent to be used in treating ...Learn More
Pivotal study of Claret's cerebral protection system wins FDA nod
The FDA has given Claret Medical the go-ahead to conduct a pivotal U.S. ...Learn More
Nuclea taps Enzo to distribute metastatic breast cancer test
Nuclea Biotechnologies has agreed to allow Enzo Clinical Labs to offer its HER-2/neu serum assay for undisclosed terms. ...Learn More
Image viewer from Carestream gains FDA OK for mobile use
The FDA has cleared Carestream Health to market its Vue Motion system for mobile image viewing. ...Learn More
Analysis finds slight improvement in FDA's 510(k) process since 2011
The FDA took an average of 166 days to review medical devices submitted under the agency's 510(k) clearance process last ...Learn More
BioFire Diagnostics pursues FDA clearance for GI panel
BioFire Diagnostics, a bioMérieux unit, has filed an application seeking 510(k) clearance from the FDA for its FilmArray ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Watch new video on value of life-changing medical technology
Medical technology has revolutionized the treatment and care of patients while decreasing overall health system costs and ...Learn More
I learned that good judgment comes from experience and that experience grows out of mistakes.
Omar Bradley, U.S. Army ...Learn More
Hospi gains FDA OK for drug delivery device
The FDA has cleared Hospi to market its Macy Catheter, which is akin to urinal catheters and is used in the rectal delivery ...Learn More
NeuroMetrix strikes distribution deal for pain relief device
DJO Global has agreed to market NeuroMetrix's SENSUS pain management device across the U.S. ...Learn More
Spinal device firm sets up national sales management group
VGI Medical, which designs and develops spinal devices, has set up a national sales management group. ...Learn More
China seeks to expedite review of some medical devices
The China Food and Drug Administration on March 1 will begin an expedited program to improve domestic access to advanced ...Learn More
A-fib study shows promise for Medtronic's heart monitor
Cardiac monitoring using Medtronic's Reveal XT Insertable Cardiac Monitor was found in a clinical study to be more effective ...Learn More
Amgen, Alliance to collaborate on cancer mutation screening
Alliance Global has entered into a deal with Amgen, for undisclosed terms, to offer next-generation sequencing-based ...Learn More
A strong FDA could pull molecular-diagnostics industry out of a rut
Molecular diagnostics have the potential to reduce waste and overtreatment while helping patients, but the field is stuck in ...Learn More
Brainsway announces Swedish launch of deep-brain stimulation device
Brainsway has launched its Deep Transcranial Magnetic Stimulation system in Sweden. ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
You cannot write for children. They're much too complicated. You can only write books that are of interest to them.
Maurice Sendak, American writer and ...Learn More
Lumenis targets $100M from Nasdaq offering
Lumenis has filed for an offering on the Nasdaq stock exchange, with the goal of obtaining $100 million. ...Learn More
Report: Ultrasound market could hit $6.1B in 3 years
A Transparency Market Research report forecasts that the global market for ultrasound systems will increase from $4.8 ...Learn More
Calif. tissue-regeneration-device firm gets $10M boost
An undisclosed investor has pumped $10 million into Endonovo Therapeutics, a maker of time-varying electromagnetic fields ...Learn More
IV catheter device firm obtains $5M loan from GE Capital
Tangent Medical, a spinoff of the University of Michigan, has secured a $5 million loan from GE Capital, Healthcare ...Learn More
New Zealand, Australia take steps to advance joint regulatory scheme
Guidance meant to help companies file evidence of conformity under a proposed framework to harmonize medical-device and drug ...Learn More
U.K. ultrasound-simulator-maker launches U.S. division
MedaPhor said it has launched a subsidiary in the U.S. and also increased its sales force there. ...Learn More
Mardil announces first human implants of VenTouch system
Two patients in Malaysia became the first to receive Mardil Medical's VenTouch technology, an implantable device designed to ...Learn More
Medtronic debuts insulin injection port in U.S.
Medtronic has announced the U.S. ...Learn More
Xvivo lands FDA date for device to preserve donor lungs
Xvivo Perfusion will meet with a panel of FDA advisers March 20 to evaluate humanitarian device exemption for the company's ...Learn More
IMRIS gains FDA clearance for latest surgical theater
The FDA has cleared IMRIS to market the latest version of its Visius surgical theater. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Download new tool kit: Value of Total Joint Replacement for People with Osteoarthritis
Total joint replacement is a valuable treatment option for many of the 27 million Americans who suffer from osteoarthritis, ...Learn More
Only in America could a refugee girl from Central Europe become secretary of state.
Madeleine Albright, former U.S. secretary of ...Learn More
Medtronic advances device to treat blocked arteries in EU, U.S.
Medtronic said its Total Across crossing catheter, designed to treat blocked or narrowed arteries in the lower extremities, ...Learn More
Medtronic divests itself of palatal-implant division
Medtronic has agreed to sell its unit that developed and distributed the Pillar Palatal Implant System to Dallas-based ...Learn More
QuantuMDx launches $50K crowdfunding campaign
QuantuMDx has launched an Indiegogo crowdfunding campaign in hopes of obtaining $50,000 and has raised about $2,500 so far. ...Learn More
Medical financing unit launched by Samsung
Samsung Financial Solutions has been established by Samsung Electronics America to help carry out the acquisition and ...Learn More
EU widens approval for Tryton Medical's side-branch stent
European regulators have granted Tryton Medical expanded CE mark approval for its side-branch stent, which was previously ...Learn More
Spanish brain-stimulation device firm sets up U.S. shop
Neuroelectrics has set up its first U.S. ...Learn More
Firm seeks funds to advance novel ear-infection device
EntraTympanic is working on a device that the company says can be used to treat ear infections without the need for ...Learn More
JustRight's pediatric surgical stapler lands FDA clearance
The FDA has cleared JustRight Surgical to market a small surgical stapler designed for use in pediatric procedures. ...Learn More
FDA finalizes rule on e-reporting of device-related adverse events
The FDA has released a final rule requiring medical device companies to report to the agency in an electronic format any ...Learn More
Snowstorm leads FDA panel to postpone review of Staar's eye device
An FDA panel meeting scheduled for today to evaluate Staar Surgical's premarket approval application for the Visian Toric ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
Watch new video on value of life-changing medical technology
Medical technology has revolutionized the treatment and care of patients while decreasing overall health system costs and ...Learn More
You are remembered for the rules you break.
Douglas MacArthur, American military ...Learn More
Review date set by FDA panel for EnteroMedics' obesity device
A panel of FDA advisers will convene on May 29 to evaluate EnteroMedics' premarket approval application for the Maestro ...Learn More
Amedica to offer more shares in IPO at lower price
Amedica has increased the number of shares it plans to sell in an initial public offering from almost 3.2 million to 3.5 ...Learn More
Merry X-Ray completes SouthWest Imaging acquisition
Merry X-Ray said it has finalized its purchase of SouthWest Imaging, a provider of X-ray equipment and support services in ...Learn More
Natera taps ProPath to offer prenatal test in U.S. market
ProPath has agreed to distribute Natera's Panorama prenatal screening assay in the U.S. for undisclosed terms. ...Learn More
Former Zimmer exec named president of Smiths Medical
Medical-device-maker Smiths Medical has tapped Jeff McCaulley to serve as its new president, replacing Srini Seshadri. ...Learn More
Olympus works to bolster medical-device presence in S. Korea
Japanese camera vendor Olympus is working to strengthen its medical-device business in South Korea in hopes of increasing ...Learn More
Preventing plagiocephaly: A conversation with Invictus Medical's Tom Roberts
Tom Roberts, CEO of San Antonio, Texas-based start-up Invictus Medical, discusses the company's approach to preventing the ...Learn More
N.Y. state OKs Ariosa to offer prenatal test to residents
Ariosa Diagnostics has secured approval from the New York Department of Health to offer its Harmony Prenatal Test in the ...Learn More
Device for sepsis detection in burn patients is in the works
U.S. researchers are working on a microfluidic device that they say could be used to quickly detect sepsis in burn patients. ...Learn More
Interventional Spine's lumbar fusion device gets expanded FDA clearance
The FDA has cleared Interventional Spine to market 11 new sizes of its Opticage system, an expandable device that the ...Learn More
FDA quality system registration, compliance completed by Molex unit
Molex subsidiary Polymicro Technologies said it has achieved registration and compliance with the FDA's quality system ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Originality is the fine art of remembering what you hear but forgetting where you heard it.
Laurence J. Peter, Canadian-American ...Learn More
Smaller version of Hansen's robotic catheter gains FDA nod
The FDA has cleared Hansen Medical to market its Magellan 6Fr system, a smaller model of its robotic catheter designed to ...Learn More
NASA licenses 2 tissue-regeneration patents to GroK
NASA has granted GroK Technologies licensing rights to a pair of patents covering its bone and muscle-tissue regeneration ...Learn More
Dako, Amgen expand partnership on companion Dx development
Dako has entered into an expanded development deal with Amgen for undisclosed terms. ...Learn More
VuCOMP names new leaders
Barry Burgdorf, who formerly served as general counsel for the University of Texas at Austin and for Samsung Austin ...Learn More
BSD Medical seeks clearance for hyperthermia device in Taiwan
BSD Medical is seeking marketing clearance in Taiwan for its hyperthermia device that administers localized therapeutic ...Learn More
Report: Asia-Pacific guided-surgery markets poised for strong growth
A Frost & Sullivan report forecasts that the image-guided and robot-assisted surgery markets in the Asia-Pacific region will ...Learn More
NxStage moves to raise awareness of home hemodialysis tech
NxStage Medical has started a campaign aimed at promoting awareness of in-home hemodialysis therapy using its System One ...Learn More
Knee soft-tissue repair device from MedShape gets FDA OK
The FDA has given MedShape 510(k) clearance to market its ExoShape system, a femoral soft-tissue fastener that the company ...Learn More
Edwards Lifesciences exec shares views on Sunshine Law implementation
Medtech companies and other health care firms must report to the CMS payments made to doctors starting March 31 of this year ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Download new tool kit: Value of Total Joint Replacement for People with Osteoarthritis
Total joint replacement is a valuable treatment option for many of the 27 million Americans who suffer from osteoarthritis, ...Learn More
Character is the ability to carry out a good resolution long after the excitement of the moment has passed.
Cavett Robert, American lawyer and professional ...Learn More
Analysis: Biotech sector poised for strong M&A activity this year
A PricewaterhouseCoopers analysis forecasts that this year will see more mergers and acquisitions in the biotech sector, ...Learn More
Clarus Ventures seeks to raise up to $375M for biotech fund
Clarus Ventures, which provides funding for biotech, diagnostic and medical device companies, is aiming to raise as much as ...Learn More
Mass. medical-sealant-maker raises $2.9M from private stock sale
Massachusetts-based Arch Therapeutics, which specializes in medical sealants, has completed its private stock offering ...Learn More
Board member named interim CEO of Hansen Medical
Hansen Medical has appointed Christopher Lowe, a member of the company's board, to serve as its CEO on an interim basis. ...Learn More
U.K. firm expands infectious disease Dx deal with Quidel
Lab21, a U.K.-based diagnostics firm, has agreed to offer Quidel's AnDiaTec products on the U.K. ...Learn More
Firms to offer cancer molecular Dx testing in Central America, Caribbean
Cancer Genetics has expanded its distribution deal with Roche Servicios for undisclosed terms. ...Learn More
EmboMedics wins funds to develop resorbable embolization product
Minnesota-based EmboMedics has secured $860,000 in a Series A financing round. ...Learn More
MRI-safe ventilator from Hamilton Medical wins FDA nod
Switzerland-based Hamilton Medical has secured FDA clearance for its Hamilton-MR1 system. ...Learn More
FDA OKs nonprescription use of AliveCor's heart monitor
AliveCor has been cleared by the FDA to market its smartphone-based electrocardiogram recorder for nonprescription use. ...Learn More
CamNtech gains FDA clearance for 2 fitness monitoring devices
The FDA has cleared CamNtech to market an electronic diary and a motion-tracking device, both of which are worn around the ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
Watch new video on value of life-changing medical technology
Medical technology has revolutionized the treatment and care of patients while decreasing overall health system costs and ...Learn More
Extending your hand is extending yourself.
Rod McKuen, American ...Learn More
Covidien gains FDA OK for surgical stapling device
The FDA has given Covidien 510(k) clearance to market its Endo GIA Reinforced Reload with Tri-Staple technology system. ...Learn More
Investors pump $4.4M into Minn. ear-surgery device firm
A group of 34 undisclosed backers has pumped $4.4 million into Preceptis Medical. ...Learn More
Pulse Therapeutics advances $1.5M funding round
A regulatory filing shows that Pulse Therapeutics has received $1.03 million in a financing round aiming for $1.5 million. ...Learn More
Calif. vascular sealant maker obtains $1.4M in financing
California-based Tenaxis Medical has secured $1.4 million of a hoped-for $1.5 million financing round. ...Learn More
Newly launched Pa. firm focuses on medtech prototype tooling
Clifford CNC Tooling Surgeon, an electrical discharge machining company, has opened in Hanover, Pa. ...Learn More
Despite obstacles, EU device sector maintains positive outlook
A Simon-Kucher & Partners survey of 45 medtech executives in Europe reveals that respondents expect pricing pressures to ...Learn More
Tech Group Europe plans facility expansion in Dublin, Ireland
Tech Group Europe, a unit of West Pharmaceutical Services, plans to add 12,000 square feet of space to its existing facility ...Learn More
Durability testing of Trinity TAVI system is completed
Transcatheter Technologies has wrapped up durability testing of its Trinity system, a third-generation transcatheter aortic ...Learn More
Neuromodulation device R&D platform from CIRTEC is available
VersaSTIM, a platform for medical technology development, has been introduced by CIRTEC Medical Systems. ...Learn More
FDA outlines medical device review priorities for this year
The FDA's device center has issued a memo detailing its three key priorities for this year. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
Take your work seriously but yourself lightly.
C.W. Metcalf, American ...Learn More
Pentagon awards about $198M in medtech supply contracts
The Department of Defense has awarded a $187.7 million contract extension to Toshiba Medical Systems and a $10 million deal ...Learn More
Mela Sciences gets $12.4M boost to relaunch melanoma device
Mela Sciences has secured $12.4 million in its latest funding round. ...Learn More
Calif. diabetes management firm receives $5.5M from investors
A group of 17 undisclosed backers has pumped $5.5 million into Intuity Medical, a Sarnoff Corp. ...Learn More
Insulin-pump-maker relocating to larger space in Billerica, Mass.
Insulet plans to transfer its base from Bedford, Mass., to a bigger space in Billerica, Mass. ...Learn More
Mazor Robotics adds sixth member to board
Michael Berman has been tapped to serve on Mazor Robotics' board of directors, which now has six members. ...Learn More
Canadian robotic-surgery-device firm plans public stock sale
Toronto-based Titan Medical, which is working on a single-orifice, robot-aided surgery system, plans to conduct a public ...Learn More
Trialogue on EU medtech regulation proposal not likely until fall
The European Commission, the European Parliament and the Council of the European Union will not convene during the first ...Learn More
St. Jude Medical reports first use of Nanostim pacemaker
A patient at Mount Sinai Hospital in New York has become the first to receive St. ...Learn More
FDA could issue medtech interoperability guidelines this year
Proposed standards that would guide companies in developing interoperable medical devices could be released this year, Dr. ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Too often reason deceives us ... but conscience never deceives.
Jean-Jacques Rousseau, Genevan philosopher and ...Learn More
Edwards' Sapien XT device wins approval in Europe
The next-generation Sapien XT system developed by Edwards Lifesciences has won CE mark approval in Europe for use in aortic ...Learn More
IPO could bring in up to $79M for Inogen
Inogen plans to launch an initial public offering in hopes of obtaining as much as $79 million. ...Learn More
Calif. cancer Dx company could pull in $19M from IPO
Biocept has launched an initial public offering of its common stock, which could raise gross proceeds of $19 million. ...Learn More
$30M funding round for PowerVision advances
California-based PowerVision has obtained $4 million in a funding round aiming for $30 million. ...Learn More
Swedish diagnostic X-ray firm bought by Fluke Biomedical
Unfors RaySafe, a diagnostic X-ray device firm based in Sweden, has been acquired by Fluke Biomedical in Washington state. ...Learn More
Philips names new CEO of North American operations
Philips has promoted Brent Shafer from chief of its home health solutions group to CEO of its operations in North America. ...Learn More
Medtech trends: The most talked-about device-makers in January 2014
MassDevice.com looks at the Internet chatter surrounding the medical device industry with some of the most searched-for ...Learn More
BioControl gains Israeli nod for clinical study of heart failure device
The Ministry of Health in Israel has given BioControl Medical the go-ahead to expand its clinical study of the CardioFit ...Learn More
Boston Scientific's device to treat clogged arteries debuts in U.S.
Boston Scientific said its OffRoad Re-entry Catheter System is now available commercially in the U.S. ...Learn More
Study calls for more efficient, transparent FDA rule-making process
A study in Health Affairs found that it takes 7.3 years on average for the FDA to produce final policies governing its ...Learn More
FDA revises list of recognized medtech standards
The FDA has issued a list of its recognized standards for premarket evaluation of medical devices that includes more than ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Man's capacity for justice makes democracy possible, but man's inclination to injustice makes democracy necessary.
Reinhold Niebuhr, American ...Learn More
Sorin continues move to expand global cannula footprint
Sorin has agreed to pay an undisclosed sum to acquire Bioengineering Laboratories' cardiac surgical cannula business, the ...Learn More
$12M investment fund aims to support Purdue-based biotech firms
Cook Medical and Purdue Research Foundation plan to launch a $12 million not-for-profit fund that aims to finance biotech ...Learn More
N.Y. vein illumination device firm secures $8M loan
New York-based AccuVein has obtained $8 million in a debt funding round headed by Horizon Technology Finance. ...Learn More
Germany expands reimbursement coverage for GI's EndoBarrier device
The German Institute for the Hospital Remuneration System has granted GI Dynamics NUB Status 1 for its EndoBarrier system, ...Learn More
U.K. regulator issues first batch of medtech briefings
The first set of Medtech Innovation Briefings has been issued by the U.K.'s National Institute for Health and Care ...Learn More
Neovasc's transcatheter mitral valve implanted in first human patient
A patient at St. ...Learn More
Medigus makes acid reflux device commercially available
Medigus is launching its endoscopy device designed to treat patients with gastroesophageal reflux disease via an outpatient ...Learn More
RxFiber's medical-grade fiber for medtech sector hits market
RxFiber has announced the commercial release of its high-tenacity medical-grade fiber tailored for the medical device ...Learn More
Federal program aims to address lack of skilled medtech workers
The White House and the Department of Labor have launched a grant-based program to address the shortage of skilled workers ...Learn More
Aurora Spine's device to promote bone ingrowth cleared by FDA
Aurora Spine has been cleared by the FDA to market its TiNano system, a PEEK-based implantable spinal fusion device designed ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
History is the unfolding of miscalculation.
Barbara W. Tuchman, American ...Learn More
Smith & Nephew boosts sports-medicine biz with ArthroCare buy
Smith & Nephew has agreed to pay $1.7 billion to purchase ArthroCare, whose products include a radio-frequency device ...Learn More
Accellent acquires Minn. medtech manufacturer
Contract manufacturer Accellent has agreed to pay an undisclosed sum to acquire Lake Region Medical, a Chaska, Minn.-based ...Learn More
Crowdfunding campaign brings in $40K for Exogen
Exogen Biotechnology has obtained $40,000 through a crowdfunding campaign on Indiegogo. ...Learn More
Calif. hypertension-device firm moves to Peoria, Ariz.
Verve Medical, which develops a device that can be used to prevent high blood pressure using radio-frequency energy, has ...Learn More
BPA used in devices might pose adverse event risks, EU panel warns
The European Commission's Scientific Committee on Emerging and Newly Identified Health Risks has issued a preliminary ...Learn More
Paris IPO could pull in about $17.4M for Crossject
Crossject looks to obtain as much as $17.4 million in an initial public offering in Paris. ...Learn More
GenCell to develop infectious disease Dx tools with Brazilian partners
Irish biotech firm GenCell Biosystems has partnered with three organizations in Brazil on a two-year project to develop ...Learn More
Autoinjector technology from Consort Medical gets FDA OK
Consort Medical has secured FDA approval for its INJ300 autoinjector system, which is used to administer the injectable drug ...Learn More
FDA OKs Given Imaging's device to detect colon cancer symptoms
The FDA has granted Given Imaging the OK to market its PillCam Colon, an ingestible pill-sized camera that could aid in the ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
Even a true artist does not always produce art.
Carroll O'Connor, American ...Learn More
Wright Medical expands extremities business with 2 acquisitions
Wright Medical has agreed to pay up to $126 million to acquire Solana Surgical and OrthoPro, both of which are focused on ...Learn More
Former Medtronic unit signs merger deal with Sansio
Medical software firm Sansio has entered into a merger deal with Physio-Control, a former subsidiary of Medtronic that was ...Learn More
Pa. maker of smartphone-based molecular Dx test obtains funds
A regulatory filing shows that Biomeme has pulled in about $1 million in a funding round. ...Learn More
Health Canada approves closure device from Sapheon
Health Canada has granted Sapheon the green light to market its VenaSeal Sapheon technology. ...Learn More
Symmetry considers shuttering its U.K. production plant
Symmetry Medical said it is exploring the possible closure of its production plant in Cheltenham, U.K., and has begun ...Learn More
Pa. patient is first to receive CoreValve System post-FDA approval
A patient at PinnacleHealth System in Pennsylvania became the first person in the U.S. ...Learn More
Medicare issues favorable ruling for Calmare pain management system
Medicare has ruled that Competitive Technologies' Calmare device may receive reimbursement coverage as a "medical necessity" ...Learn More
Inflatable-balloon system from Obalon debuts in Europe
Obalon Therapeutics is launching its inflatable-balloon system, designed to help obese patients shed weight, in Europe. ...Learn More
CareFusion gets FDA nod on vertebral balloon technology
The FDA has cleared CareFusion to market its AVAflex Vertebral Balloon System. ...Learn More
FDA officials meet with Apple execs to consider mHealth apps
A public calendar for the FDA shows that agency officials met in December with senior executives at Apple to talk about ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Life has a funny way of becoming ordinary as soon as it can.
Colm Toibin, Irish ...Learn More
Covidien's surgical staple system gains approval in Japan
Covidien has received the green light to market its Endo GIA Reinforced Reload with Tri-Staple technology in Japan. ...Learn More
Toshiba, Varian enter $515M imaging supply agreement
Varian Medical Systems has struck a three-year supply deal with Toshiba Medical Systems for $515 million. ...Learn More
$20M funding round for PowerVision includes J&J, Medtronic
PowerVision has secured $20 million in the first tranche of its Series D funding round, which included Johnson & Johnson and ...Learn More
Clarient Diagnostic to offer bioMérieux's melanoma test
Clarient Diagnostic Services has expanded its offerings to include the THxID BRAF test kit from bioMérieux. ...Learn More
Clinical lab Dx tests help fuel 2013 profit growth for Roche
Roche generated $12.4 billion in net income last year, up 18% from about $10.5 billion in 2012. ...Learn More
Gore begins trial enrollment for thoracic branch device
W.L. Gore & Associates said it has begun patient enrollment in a U.S. ...Learn More
Lucigen eyes 2015 market release of C. difficile test
Lucigen hopes to gain a share of the point-of-care diagnostic market with its rapid molecular diagnostic tests currently ...Learn More
GE Healthcare to install low-dose CT machine at Kan. hospital
Wesley Medical Center in Wichita, Kan., is investing more than $1 million to deploy GE Healthcare's CT machine in its ...Learn More
FDA seeks expedited approval of high-need medical technologies
The FDA is exploring a new regulatory framework that would speed up approval of high-risk medical technologies meant to ...Learn More
Angle hopes for FDA approval of cell separation device by September
Angle will submit an FDA application for its Parsortix cell separation system in March with the hope of obtaining regulatory ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
A bee is never as busy as it seems; it's just that it can't buzz any slower.
Kin Hubbard, American ...Learn More
Planned IPO could pull in up to $38M for Amedica
Amedica has announced plans to launch an initial public offering that could bring in as much as $38 million. ...Learn More
OneBreath gets $2.87M boost to help advance ventilators
A funding round has pulled in $2.87 million for OneBreath, a maker of rechargeable ventilators tailored for use in ...Learn More
Automated Dx device, TB test helped boost Q4 profit for Qiagen
Qiagen posted $87.8 million in adjusted net income during the fourth quarter, up from $82.8 million during the same period a ...Learn More
Toshiba signs ultrasound supply deal with N.Y. hospital
Our Lady of Lourdes Memorial Hospital in New York state has awarded a supply contract to Toshiba America Medical Systems. ...Learn More
Medtronic shifts Mid-East/Africa headquarters to Dubai, UAE
Medtronic said its Middle East/Africa regional office in Beirut, Lebanon, has been transferred to DuBiotech research park in ...Learn More
EU approves Claret's device used to prevent cerebral embolism
Claret Medical has earned the CE mark to market its Sentinel system in Europe. ...Learn More
A problem for all of us: Philips Healthcare clinical informatics CEO Michael Mancuso on patient safety
Philips Healthcare clinical informatics CEO Michael Mancuso tells MassDevice.com how he envisions medtech companies coming ...Learn More
Mich. facility performs first post-approval implants of Argus II device
The Kellogg Eye Center at the University of Michigan has performed the first post-approval implantations of Second Sight ...Learn More
LabCorp, Epic partner to advance blood fluid biopsy device
Laboratory Corporation of America has agreed to work with Epic Sciences to expedite clinical studies in Europe that use ...Learn More
Novel insulin pump could undergo human trials in 2 years
A new insulin pump that is comparable in size to a wristwatch and implanted in the abdomen is set to undergo human studies ...Learn More
Ill. governor touts new hub for medical-device startups
During his State of the State speech Wednesday, Illinois Gov. ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
There is always an easy solution to every human problem -- neat, plausible, and wrong.
H.L. Mencken, American journalist and ...Learn More
Medtronic gains expanded FDA approval for thoracic stent
The FDA has granted Medtronic expanded approval for its Valiant Captivia Thoracic Stent Graft, which previously was ...Learn More
Report: VC funding in Midwestern medtech sector hit $423M last year
A BioEnterprise report indicates that although biotech investment in the Midwest was down last year, venture funding for ...Learn More
Va. spinal device firm plans to launch IPO
K2M has filed for an initial public offering, although it did not disclose how much it intends to raise from the offering. ...Learn More
St. Jude Medical restructures, shuffles management deck
St. ...Learn More
U.K. diagnostics firm raises $3.2M for OCT scanner
A Series A2 funding round has pulled in $3.2 million for Michelson Diagnostics. ...Learn More
Canadian microarray diagnostics firm obtains $1.3M
SQI Diagnostics has secured $1.3 million in a private shares offering round. ...Learn More
Saint Luke's cardiac research gets boost from Boston Scientific
Saint Luke's Mid America Heart Institute will use a $3.4 million grant to finance research into innovative and minimally ...Learn More
Blood test, imaging method among winners of TBI tech challenge
Among the first recipients of a $300,000 prize in the Head Health Challenge are a blood assay that assesses brain injury and ...Learn More
Benvenue's device to treat spinal fractures wins FDA nod
Benvenue Medical has been cleared by the FDA to market its Kiva VCF Treatment System, a PEEK-OPTIMA-based implant designed ...Learn More
FDA clears PAD device from AtheroMed
The FDA has granted AtheroMed approval for its Phoenix Atherectomy System designed to eradicate plaque in arterial walls as ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
It is the loose ends with which men hang themselves.
Zelda Fitzgerald, American ...Learn More
Edwards Lifesciences wins EU nod for third-gen heart valve
Regulators in Europe have given Edwards Lifesciences the CE mark for its Sapien 3 system, a third-generation version of the ...Learn More
Firms team up to offer single-use video intubation technology
Fujifilm SonoSite and Vivid Medical are collaborating to offer the VividTrac video intubation system. ...Learn More
N.Y. imaging-device provider adds service and parts to offerings
Staten Island, N.Y.-based Monarch Medical said it has added parts and services to its core business of buying and selling ...Learn More
CFO of Covidien to step down after 19 years in the role
Charles Dockendorff is stepping down as chief financial officer of Covidien by the end of 2014. ...Learn More
Quantel Medical gains approval for eye device in Europe
Quantel Medical has earned the CE mark in Europe for its Optimis Fusion system and plans to launch the device immediately. ...Learn More
China and India poised to see ultrasound market growth, report predicts
A GlobalData report forecasts that the diagnostic ultrasound market in China could be worth $1.3 billion by 2019, while ...Learn More
U.K. patient is first to receive St. Jude's leadless pacemaker
A 77-year-old patient in London has become the first to receive St. ...Learn More
Molecular Dx device from QuantuMDx could hit market next year
QuantuMDx plans to conduct internal tests of its point-of-care molecular diagnostic device through June and a beta trial ...Learn More
Siemens' radiation oncology workflow solution obtains FDA clearance
The FDA has awarded 510(k) clearance for Siemens Healthcare's RT Pro edition software that was designed to boost radiation ...Learn More
Cochlear seeks to overturn cochlear implant-patent verdict
A federal jury in California has ordered Cochlear to pay $131.2 million in damages for allegedly violating cochlear-implant ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
A person often meets his destiny on the road he took to avoid it.
Jean de la Fontaine, French writer and ...Learn More
AdvaMed works with industry to align Taiwan medtech rules with U.S. policy
AdvaMed and the Taiwan Advanced Medical Technology Association, a group formed last summer by 18 U.S. ...Learn More
Stock sale could pull in $14M for Atossa Genetics
Atossa Genetics is looking to obtain roughly $14 million through an offering of company shares valued at $2.40 apiece. ...Learn More
DSM launches facility to provide medical-device coating services
DSM has set up a new facility to provide the medical-device sector with a full line of coating services, ranging from ...Learn More
Halifax Biomedical names new C-suite leaders
Halifax Biomedical has appointed John Simon to serve as chief operating officer and Erik Giphart to serve as chief ...Learn More
Masimo gains EU approval for O3 regional oximeter
European regulators have given Masimo the CE mark for its O3 regional oximeter, designed to monitor arterial blood ...Learn More
$8M grant offered for U.K. stent biomaterials program
A U.K. ...Learn More
Third-year results from S.M.A.R.T. stent trial shared by Cordis
Cordis, a Johnson & Johnson unit, reported positive results from the third year of a clinical study evaluating the use of ...Learn More
Hemova wins Ariz. bioscience contest for vascular access system
Hemova Medical has been named one of the winners of the BioAccel Solutions Challenge in Arizona for its vascular access ...Learn More
Guidelines on use of animal-derived tissue in medtech amended by FDA
The FDA has issued draft guidance outlining what information companies should include in premarket applications and document ...Learn More
FDA seeks to boost device trial participation among women
The FDA has announced new protocols to ensure that post-approval medical-device research includes an appropriate number of ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Correction
In Friday's AdvaMed SmartBrief, a headline about a Series D funding round for a Pa. ...Learn More
You are never too old to set another goal or to dream a new dream.
C.S. Lewis, Irish writer and ...Learn More
Biotronik wins EU nod for device to treat femoropopliteal lesions
European regulators have granted Biotronik the CE mark to market its Passeo-18 Lux Drug Releasing Balloon, designed to treat ...Learn More
Investors pump $61.2M into Medfusion
Medfusion has raised $61.2 million from 30 undisclosed investors, bringing the company closer to its $65.7 million goal for ...Learn More
Pa. maker of surgical sealants closes $26.3 Series D round
Cohera Medical has reached its $26.3 million goal for its Series D funding round after obtaining $9.3 million from ...Learn More
Surgical-closure-device firm receives $4.3M funding boost
A Series C funding round has brought in $4.3 million for ZipLine Medical, a maker of noninvasive surgical skin-closure ...Learn More
Covidien launches innovation hub in India
Covidien has announced the launch of its first Center of Innovation in India. ...Learn More
Arkray Healthcare to pay $15.9M for Span Diagnostics
Arkray Healthcare, the Indian unit of Japanese diagnostics firm Arkray, has agreed to pay Span Diagnostics around $15.9 ...Learn More
Analysis shows promising results for Smith & Nephew's PICO device
A clinical study analysis indicated that patients who received negative pressure wound therapy using Smith & Nephew's PICO ...Learn More
Study using Mako robotic surgery device could begin this year
Stryker has announced that it will initiate a clinical study of the Mako robotic surgery system, which it acquired recently, ...Learn More
Alere announces EU launch of Influenza A & B Test
Alere has announced the commercial release of its Influenza A & B Test in the U.K., France, Germany, Switzerland, Austria, ...Learn More
FDA clears laparoscopic surgery device from Covidien
The FDA has cleared Covidien to market its LigaSure Maryland system, a jaw open/laparoscopic sealer/divider designed to ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
I freed a thousand slaves; I could have freed a thousand more if only they knew they were slaves.
Harriet Tubman, American ...Learn More
Device tax injures innovative companies, senator says
The 2.3% medical device tax is hurting innovative companies and is impeding their ability to gain a global competitive edge, ...Learn More
Quest Diagnostics expands lab testing footprint with Solstas buy
Quest Diagnostics has agreed to pay roughly $570 million to acquire Solstas Lab Partners. ...Learn More
Intuitive to purchase shape-sensing tech from Luna Innovations
Intuitive Surgical, maker of the da Vinci robotic surgery system, has signed a deal to buy Luna Innovations' shape-sensing ...Learn More
RTI, Mazor Robotics sign supply deals with hospital GPOs
RTI Surgical has struck a deal to supply Yankee Alliance, a hospital group purchasing organization, with its surgical ...Learn More
Swiss, German regulators sign regulatory networking agreement
Swissmedic has signed a memorandum of understanding with the Federal Institute for Drugs and Medical Devices in Germany. ...Learn More
In defense of renal denervation: Managing expectations in the aftermath of Symplicity HTN-3
Cardiologist Dr. ...Learn More
Calif. device firm obtains funds, completes enrollment for glaucoma stent trial
AqueSys has raised $43.6 million in Series D financing, which President and CEO Ron Bache said would help the company ...Learn More
Firm prepares to market catheter-based fluid delivery device
RenovoRx, a medical-device startup based in San Jose, Calif., is pursuing FDA clearance to market its fluid delivery ...Learn More
Arizona Heart Foundation to use Toshiba's ultrasound devices
Toshiba America Medical Systems has installed a Viamo scanner and eight units of its Aplio 500 ultrasound devices at the ...Learn More
Medtronic's pacemaker gets FDA OK for full-body MRI scans
The FDA has granted Medtronic approval to market its SureScan pacemaker without MRI scanning limitations. ...Learn More
FDA proposes guidelines on custom device exemption rules
The FDA has released draft guidance explaining a provision under the FDA Safety and Innovation Act that would allow certain ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
To have what we want is riches, but to be able to do without is power.
George MacDonald, Scottish ...Learn More
EndoChoice gains Canadian OK for endoscopy device
EndoChoice has secured a license to sell the Fuse Full Spectrum Endoscopy device in Canada. ...Learn More
Public stock offering could bring in $55M for NanoString
NanoString Technologies, which launched an initial public offering last summer, looks to raise $55 million in a follow-on ...Learn More
Ga. cardiovascular device firm looks to obtain $25M
Georgia-based CorMatrix Cardiovascular hopes to raise $25 million in an equity funding round. ...Learn More
Atrial fibrillation device company advances $4M funding round
A funding round aiming for $4 million has brought in $2.5 million for Cardialen. The company, which has operations in St. ...Learn More
Tegra Medical promotes COO to president and CEO
Tegra Medical has promoted J. Mark King from chief operating officer to president and CEO. ...Learn More
Echo seeks approval for wireless glucose monitor in Europe
Echo Therapeutics has submitted an application seeking CE mark approval for its continuous glucose monitoring device ...Learn More
New rules for importing unregistered devices issued in Peru
DIGEMID, Peru's medtech regulator, has issued new policies for importing unregistered medical devices in that country. ...Learn More
Prestizia partners with French agency to develop HIV/AIDS tests
Prestizia, a unit of Theradiag, has agreed to work with the National Center for Scientific Research in France to create an ...Learn More
Sensogram's health, activity monitoring devices could be available this year
Sensogram said it will launch a pair of wearable devices this year meant to monitor health and physical activity. ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
I have never been hurt by what I have not said.
Calvin Coolidge, 30th U.S. ...Learn More
Shire sells Dermagraft to Organogenesis with no upfront payment
Dermagraft, a unit of Shire focused on developing skin graft material for treatment of diabetic foot ulcers, has been ...Learn More
Calif. endoscopy device firm advances $10.6M funding round
A debt funding round aiming for $10.6 million has pulled in $4.8 million for Avantis Medical Systems, a California-based ...Learn More
Funding round pulls in almost $900K for EndoShape
EndoShape has raised $898,000 in a round of financing from nine undisclosed backers. ...Learn More
CEO of Zynex downsizes board as part of restructuring plan
Thomas Sandgaard, CEO of rehabilitation-device firm Zynex, has cut the company's board in half as part of a larger ...Learn More
Greatbatch seeks approval for pain-therapy device in Europe
Greatbatch has submitted an application seeking CE mark approval in Europe for use of its spinal-cord stimulation device in ...Learn More
India to create board to evaluate medical devices
A Medical Technology Assessment Board is set to be established by the Department of Health Research in India to review new ...Learn More
Study shows promising results for Ekos' endovascular device
A study appearing in the journal Circulation showed that patients with submassive pulmonary embolism substantially reduced ...Learn More
MBio prepares to launch HIV test in sub-Saharan Africa
MBio Diagnostics is preparing to make its CD4 T-cell enumeration assay commercially available in sub-Saharan Africa this ...Learn More
Trials underway for Ischemia Care's blood-based stroke test
Ischemia Care is conducting clinical studies of its ISCDX test, designed to identify where in a patient's body an ischemic ...Learn More
FDA clears Argon's retrievable inferior vena cava filter
Argon Medical Devices has been cleared by the FDA to market its OptionELITE system, a retrievable inferior vena cava filter. ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Goodwill is the one and only asset that competition cannot undersell or destroy.
Ludwig Borne, German political writer and ...Learn More
Medtronic gains FDA OK for heart valve sooner than expected
The FDA has granted Medtronic approval to market its CoreValve transcatheter aortic valve replacement device for use in ...Learn More
Maker of leukemia Dx test obtains $950K in financing
QuanDx has secured $950,000 in financing from 10 undisclosed backers and looks to obtain $550,000 more. ...Learn More
Former Accuray executive joins EOS imaging as CMO
Fabienne Hirigoyenberry-Lanson has been tapped to serve as chief medical officer at EOS imaging. ...Learn More
Irish orthopedic device firm receives $2.4M funding boost
A financing round has pulled in $2.4 million for X-Bolt Orthopaedics. ...Learn More
Studies show positive results for Alere's combo HIV assay
A study appearing in the journal PLOS One and another in the Journal of Clinical Virology indicated that Alere's Determine ...Learn More
Google begins testing of "smart contact lens" for diabetes patients
Google announced Thursday that it is testing a prototype of its "smart contact lens" designed to provide readings of glucose ...Learn More
Device to increase shelf life of donated blood is in the works
New Health Sciences is working on a device, called Hemanext, that stores donated blood in an anaerobic bag to keep oxygen ...Learn More
Test to detect potential developmental delays in children gets FDA OK
Affymetrix has received clearance under the FDA's de novo program to market its CytoScan Dx test. ...Learn More
President signs omnibus funding bill
A $1.1 trillion budget proposal that cleared the House and Senate last week has been signed into law by President Barack ...Learn More
FDA proposes standards on medtech computational modeling studies
A draft document issued by the FDA outlines its recommended guidelines for standardizing how computational modeling and ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
The human brain is a wonderful organ. It starts to work as soon as you are born and doesn't stop until you get up to deliver a speech.
George Jessel, American ...Learn More
Carlyle to pay $4.15B for J&J's ortho-clinical Dx business
The Carlyle Group has agreed to pay Johnson & Johnson $4.15 billion to acquire its ortho-clinical diagnostics division in a ...Learn More
Covidien completes sale of surgical-device portfolio to Integra
The sale of Covidien's Confluent Surgical portfolio, which includes surgical shields and sealants, to Integra LifeSciences ...Learn More
BioMérieux wraps up $486M purchase of BioFire Diagnostics
BioMérieux has completed its purchase of BioFire Diagnostics for $486 million in cash and assumed debt. ...Learn More
AJL Ophthalmic taps Oasis Medical to market eye device
AJL Ophthalmic has agreed to allow Oasis Medical to market its Intacs corneal implant exclusively. ...Learn More
British medtech firm to present cervical cancer Dx system in Dubai, UAE
British medical-device firm Zilico will showcase its ZedScan system, which is used in conjunction with colposcopy on women ...Learn More
Firm raises $4M for device to administer drugs straight into the brain
A Series B funding round has brought in $4 million for Alcyone LifeSciences. ...Learn More
New stool-sample-collection device could hit market this summer
SIB Medical Technologies is working on a new prototype of a device that offers a simpler way to collect stool samples at ...Learn More
Duracell commercial features deaf NFL player
Derrick Coleman, who lost his hearing when he was 3 years old, is now a running back for the Seattle Seahawks and is the ...Learn More
St. Jude Medical unit gets FDA OK for heart arrhythmia device
The FDA has given Irvine Biomedical, a unit of St. Jude Medical, the go-ahead to market its Therapy Cool Flex system. ...Learn More
FDA OKs latest home health hub from Alere Connect
The FDA has cleared Alere Connect to market HomeLink, the latest addition to its home health hub product line. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Imaginary evils are incurable.
Marie von Ebner-Eschenbach, Austrian ...Learn More
Thermo's pending purchase of Life Tech wins Chinese approval
Thermo Fisher's pending purchase of Life Technologies for $15.8 billion has received the go-ahead from the Ministry of ...Learn More
2014 M2D2 medtech innovation challenge to focus on 3 areas
The 2014 New Venture Competition, organized by the Massachusetts Medical Device Development Center, will highlight ...Learn More
AkesoGenX buys rights to experimental cancer therapy device
AkesoGenX has agreed to acquire the rights to Therm Med's external radiofrequency generator, an experimental device designed ...Learn More
Mo. cancer drug delivery device firm obtains $2.95M
A debt funding round aiming for $5 million has pulled in $2.95 million for Veran Medical Technologies. The St. ...Learn More
7 cancer facilities in Algeria to use Elekta's devices
Elekta has received an order to supply seven cancer facilities in Algeria with its Mosaiq oncology IT solutions, Synergy and ...Learn More
Medtronic CEO Ishrak: Value-based health care is the only way to save medtech
Medtronic CEO Omar Ishrak tells MassDevice.com that medtech must embrace value-based health care if it wants to escape the ...Learn More
CMS issues final ruling for image-guided lumbar decompression
A final ruling issued by the CMS will permit coverage with evidence development for percutaneous image-guided lumbar ...Learn More
NIH taps bioprinting to create better tissue models for research
The NIH's National Eye Institute and the National Center for Advancing Translational Sciences have partnered with Organovo ...Learn More
Third-generation cardiac mapping device from Topera gains FDA nod
Topera Medical has been cleared by the FDA to market its third-generation 3D Mapping System, which features the company's ...Learn More
Budget proposal to restore FDA user fees praised by AdvaMed
The 2014 omnibus funding bill, which would reinstate about $85 million in FDA user fees for medical devices and drugs, has ...Learn More
Lawmaker to include device-tax repeal in employment-benefits proposal
A House bill that would extend emergency unemployment benefits for another year is set to be introduced this week by Rep. ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Those who have least to do are generally the most busy people in the world.
Samuel Richardson, British ...Learn More
Endo Health agrees to sell remainder of urology biz for $130M
The remaining HealthTronics urology-device unit of Endo Health Solutions will be sold to Altaris Capital Partners for $85 ...Learn More
Onciomed gets $5.5M boost to test obesity device in humans
California-based Onciomed has secured $5.5 million in a Series A round of financing, which the company will use in part to ...Learn More
Nuclea enters development partnerships for cancer tests
Nuclea has entered into a deal with Nuvera Biosciences to jointly create a gene-based test to predict a breast cancer ...Learn More
U.K. maker of OCT imaging device obtains $3.25M
A Series A2 funding round has pulled in $3.25 million for Michelson Diagnostics. ...Learn More
Stentys strikes new distribution deals in Asia
Stentys said it has signed deals with undisclosed distributors for its stent offering in Hong Kong, Malaysia and Singapore. ...Learn More
U.S., EU regulators OK MediValve's cardiovascular device
The acWire Guidewire developed by Israeli firm MediValve has received 510(k) clearance from the FDA as well as CE mark ...Learn More
Medinol initiates 2 clinical studies of artery device
Medinol has launched two studies of its NIRsupreme stent designed to aid in the prevention of narrowed arteries, according ...Learn More
Firm wraps up enrollment for chronic sinusitis implant trial
Intersect ENT, whose backers include Medtronic, has closed enrollment in a clinical study of its third drug-eluting implant ...Learn More
MHealth developer unveils wearable tools at CES
IHealth showcased three mHealth offerings at the 2014 Consumer Electronics Show that people can use to remotely monitor ...Learn More
Senate and House agree to reinstate $85M in FDA user fees
The Senate and the House have reached an agreement to restore roughly $85 million in FDA user fees for medical devices and ...Learn More
For more:
Read the statement from AdvaMed President and CEO Stephen J. ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
People have discovered that they can fool the devil; but they can't fool the neighbors.
Francis Bacon, British writer and ...Learn More
Edwards gains FDA nod for advanced heart valve trial
The FDA has granted Edwards Lifesciences investigational device exemption approval to conduct a clinical study of its Sapien ...Learn More
Vocera pays $3.5M for medical-alarm management company
Vocera Communications has agreed to pay $3.5 million to purchase mVisum, a company that develops smartphone-based tools to ...Learn More
Protein test maker stretches Series E round to $14.4M
Biodesix has obtained an additional $6.1 million in Series E financing, raising its total for that round to $14.4 million. ...Learn More
Firms expand collaboration to develop molecular Dx tests
Qiagen has expanded its partnership with Exosome Diagnostics to create noninvasive in vitro molecular diagnostic tests for ...Learn More
Genentech exec is named chief medical officer of Roche
Sandra Horning has been tapped to serve as chief medical officer as well as head of global product development at Roche. ...Learn More
GlySure is on track to win EU approval for glucose monitor, CEO says
GlySure could gain CE mark approval in Europe for the company's Continuous Glucose Monitoring System during the second ...Learn More
Firm raises $46.5M to support glaucoma-device studies
Ivantis has stretched its Series B financing to $46.5 million after raising $14 million more for that round. ...Learn More
IPhone-based pulse oximeter from Zensorium debuts
Tinké, a pulse oximeter that links to an iPhone application, was introduced by Singapore-based startup Zensorium at the 2014 ...Learn More
FDA OKs new MRSA test from BD Diagnostics
The FDA has cleared BD Diagnostics to market the BD Max MRSA XT test, its second assay that can be used to diagnose strains ...Learn More
CareFusion finalizes settlement deal with Justice Department
CareFusion has finalized its $41 million settlement with the Justice Department involving a federal probe into the marketing ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Temptations, unlike opportunities, will always give you many second chances.
O.A. Battista, Canadian-American chemist and ...Learn More
$290M sale of Wright's hip-and-knee implant unit is finalized
The sale of Wright Medical's OrthoRecon hip-and-knee implant unit to MicroPort Scientific has been completed. ...Learn More
IPO could bring in $48M for KineMed
California-based KineMed looks to obtain $48 million in an initial public offering. ...Learn More
QuantuMDx plans crowdfunding campaign to advance malaria test
QuantuMDx will conduct an Indiegogo crowdfunding campaign next month to fund clinical trials of its Q-POC system, a handheld ...Learn More
Indonesia announces new medtech e-registration system, accessories rules
Indonesia has announced changes to its electronic medical-device registration system, including that the country's online ...Learn More
NIMH backs study of Tal Medical's antidepression device
Tal Medical has received a grant from the National Institute of Mental Health to conduct a 90-participant study of its ...Learn More
Insurer agrees to cover Sequenom unit's fetal assay
Sequenom Laboratories, a unit of Sequenom, has won reimbursement coverage from a benefits provider for its MaterniT21 Plus ...Learn More
Novel technique for evaluating wrist joints uses active MRI
Scientists at the University of California at Davis have discovered a way to generate videos of moving wrist joints using a ...Learn More
FDA OKs gram-negative bacteria test from Nanosphere
The FDA has cleared Nanosphere to market an in vitro diagnostic assay that can detect more than 90% of gram-negative ...Learn More
FDA labels Covidien's ventilator recall as Class I
A recall initiated by Covidien involving its Puritan Bennett 840 Series ventilators purchased from Aug. 1, 2008, to Oct. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
The years between 50 and 70 are the hardest. You are always being asked to do things, and yet you are not decrepit enough to turn them down.
T.S. Eliot, American-British ...Learn More
Carl Zeiss acquires intraocular-lens manufacturer for $70M
Carl Zeiss Meditec has agreed to buy all the assets of Aaren Scientific, an intraocular-lens-maker, for $70 million. ...Learn More
Globus Medical to purchase maker of surgical robotic systems
Globus Medical has agreed to pay an undisclosed sum to purchase Excelsius Surgical. ...Learn More
Fla. cataract-surgery-device firm obtains $10M
LensAR has received $10 million from 14 backers, although it did not disclose how it would use the funding. ...Learn More
Maker of cancer imaging device for surgery gets new CEO, raises $6.85M
A Series B funding round has pulled in $6.85 million for Avelas Biosciences, maker of the Avelas Cancer Illuminator, or ...Learn More
EU approves larger-sized TAVI device from Direct Flow Medical
European regulators have given Direct Flow Medical the CE mark to market its 29-millimeter TAVI system, an anti-leak ...Learn More
Series A funding round for Irish startup includes Covidien
Fire1, an Irish startup focused on novel therapeutic devices, has closed its Series A funding round that includes Covidien. ...Learn More
Firms partner to offer lung-cancer test in Chinese market
Epigenomics has entered into a licensing and distribution agreement with Wuhan Kindstar Clinical Diagnostics for undisclosed ...Learn More
Master's program in medtech innovation launched at U. of Minn.
A new master's degree program on medical-device innovation has been introduced at the University of Minnesota. ...Learn More
Eye surgical sealant from Ocular Therapeutix gains FDA OK
Ocular Therapeutix has secured FDA approval for its ReSure Sealant gel, which is used to seal leaking corneal incisions in ...Learn More
FDA makes distinction between point-of-care and OTC glucose monitors
Two proposals from the FDA outline separate guidelines for over-the-counter blood glucose monitors and those used at the ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Democracy is a small hard core of common agreement, surrounded by a rich variety of individual differences.
James Conant, American chemist, university president and ...Learn More
Cantel Medical expands acquisition push with Sterilator buy
Cantel Medical continues on the acquisition trail with its recent purchase of Sterilator Co., maker of sterilization ...Learn More
Baxter wraps up sale of renal replacement therapy biz
The sale of Baxter International's continuous renal replacement therapy unit to Nikkiso America has been finalized. ...Learn More
Sapheon gets $10M boost to launch venous reflux device in U.S.
Sapheon, maker of the VenaSeal Sapheon Closure System designed to treat venous reflux that triggers varicose veins, has ...Learn More
UK stent graft maker plans to go public in U.S.
Lombard Medical Technologies, maker of stent grafts designed to treat patients with abdominal aortic aneurysms, is looking ...Learn More
Zynex strikes Chinese deal for stroke rehabilitation device
DIH Medical Technologies has entered into a five-year deal to exclusively offer Zynex's NeuroMove system on the Chinese ...Learn More
Medtech trends: The most talked-about device makers in December 2013
MassDevice.com looks at the Internet chatter surrounding the medical device industry with some of the most-searched-for ...Learn More
Study shows promising results for Inspire's sleep apnea device
A 126-participant study appearing in the New England Journal of Medicine indicated that patients reduced the severity of ...Learn More
Sinus dilation device from SinuSys lands FDA clearance
SinuSys has been cleared by the FDA to market its Vent-Os technology, designed to make it more tolerable for patients under ...Learn More
Advanced patient monitor from EarlySense wins FDA nod
The FDA has granted EarlySense clearance for a new version of its patient monitoring tool, which employs a pad-sized sensor ...Learn More
FDA issues timeline for 510(k) review communications
The FDA has posted on its website a new chart detailing typical communications between medical device companies and the ...Learn More
LabCorp's IDE application for A-fib companion Dx test accepted by FDA
Laboratory Corp. ...Learn More
Medical Device Complaints, MDRs and Reports
Tuesday, March 18 – Wednesday, March 19Hilton Alexandria Old Town, Alexandria, Va.FDA personnel and expert industry ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Things start out as hopes and end up as habits.
Lillian Hellman, American ...Learn More
Becton, Dickinson and Co. pays $40M for medical Dx device firm
Becton, Dickinson and Co. ...Learn More
Mass. laparoscopic surgery device firm obtains $2.9M
A round of financing from eight undisclosed backers has pulled in $2.9 million for Cambridge Endoscopic Devices. ...Learn More
Funding round brings in $1.6M for ArthroMeda
ArthroMeda has raised $1.6 million from 12 investors, bringing the company closer to its $2 million financing target for ...Learn More
Stryker enters exclusive tech partnership with NeuroLogica
Stryker has struck an exclusive distribution deal with NeuroLogica. ...Learn More
Ky. spinal device maker hopes to secure $1.25M in financing
Kentucky-based Cardinal Spine is looking to obtain $1.25 million in a funding round, for which it has raised $300,000. ...Learn More
Report: Global self-care device market could hit $16.9B in 5 years
The global market for self-care medical devices such as blood glucose and sleep apnea monitors could reach $16.9 billion by ...Learn More
Philips acquires portable home nebulizers from Irish firm
Philips has signed a deal to purchase the portable home nebulizer portfolio of Aerogen, an Ireland-based maker of acute-care ...Learn More
Partnership aims to develop companion Dx for cancer therapy
Leica Biosystems has entered into a co-development deal with Arno Therapeutics. ...Learn More
Radiology table from Diagnostic Medical gains FDA OK
Diagnostic Medical Systems has been cleared by the FDA to market its Platinum radiology table, designed for radiography and ...Learn More
FDA gives Delphinus Medical nod on breast imaging system
The FDA has given Delphinus Medical Technologies 510(k) clearance to market its SoftVue system, a whole breast ultrasound ...Learn More
Molecular Diagnostics and the Changing Landscape: Considerations and Implications
Wednesday, March 5 – Thursday, March 6Marriott at Metro Center, Washington, D.C.FDA and industry speakers address the ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Spoon feeding in the long run teaches us nothing but the shape of the spoon.
E.M. Forster, British ...Learn More
Medtronic acquires infection device firm for $160M
Medtronic has agreed to acquire Tyrx for $160 million in upfront cash plus potential milestone payments. ...Learn More
Calif. migraine device maker receives $2.2M in financing
An undisclosed backer has pumped $2.2 million into eNeura Therapeutics. ...Learn More
CFO and 3 board members of Mela Sciences step down
Richard Steinhart has stepped down as chief financial officer at Mela Sciences, while Mindy Meads, Mark Fabiani and Anne ...Learn More
Boston Scientific's interventional cardiology unit gets new CMO
Craig Thompson has been tapped to serve as senior vice president and chief medical officer of Boston Scientific's ...Learn More
Thermo Fisher moves to satisfy deal with EU regulators involving Life Tech buy
Thermo Fisher Scientific has agreed to sell its magnetic beads, gene modulation and cell culture businesses to GE ...Learn More
Patient enrollment begins for Medtronic's A-fib study
Medtronic has enrolled the first patient in a clinical study of its Phased Radiofrequency device, designed to treat patients ...Learn More
Cancer facility gets $8M boost from Mass. biotech center
The Center for Personalized Cancer Therapy, a joint effort between the Dana-Farber/Harvard Cancer Center and the University ...Learn More
Lacrimal duct balloon catheter from FCI wins FDA nod
FCI Ophthalmics has received FDA approval for its OphtaCath system, a lacrimal duct balloon catheter designed to treat ...Learn More
Zensorium designs Android version of Tinke health tracker
Zensorium is exhibiting the Android version of its Tinke electronic device, which gathers medical data such as heart rate, ...Learn More
FDA OKs Smiths Medical's device to help manage pain
The FDA has cleared Smiths Medical to market the CADD-Solis system, which features the firm's Programmed Intermittent Bolus ...Learn More
Investigational Device Exemption (IDE) Submissions Workshop
Wednesday, Feb. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Feb. 27 – Friday, Feb. 28Hyatt Arlington at Key Bridge, Arlington, Va. ...Learn More
The only person who is educated is the one who has learned how to learn and change.
Carl Rogers, American ...Learn More
Grifols to support purchase of Novartis Dx unit with $1.5B loan
Grifols has secured a bridge loan worth $1.5 billion from Morgan Stanley, Nomura and BBVA. ...Learn More
SchureMed relocates, but maintains operations in Mass.
SchureMed has transferred its operations from Braintree, Mass., to a bigger 37,000-square-foot facility in Abington, Mass., ...Learn More
Mich. electronic-components firm eyes expansion in medtech sector
Firstronic, which provides electronic components to the automotive industry, is planning to further diversify into the ...Learn More
Harmonized nano product labeling guidelines released by ISO
Guidelines released by the International Organization for Standardization aims to harmonize the labeling of nano devices and ...Learn More
LeMaitre announces direct-sales expansion in Norway, Australia
Burlington, Mass.-based LeMaitre Vascular will supply its vascular implants and related devices directly to hospitals in ...Learn More
InVivo wins FDA nod to change protocols for scaffold trial
The FDA has granted InVivo Therapeutics conditional investigational device exemption approval to modify the protocols for ...Learn More
Globus' patented tech addresses limitations of rod fixation tools
A patent has been granted to Globus Medical for its transverse fixation tool used with spinal fixation technologies. ...Learn More
Cancer facility in Australia installs Elekta's devices
Oceania Oncology in Australia has installed Elekta's Monaco 5 device for planning radiation treatment and could start using ...Learn More
FDA lowers regulatory bar for certain intra-aortic devices
The FDA has downgraded intra-aortic balloons and pumps used during cardiac and noncardiac procedures as well as those ...Learn More
GE Healthcare unit initiates anesthesia device recall
Vital Signs Devices has announced a voluntary recall involving its Multi Absorber Original anesthesia device with lot ...Learn More
510(k) Submissions Workshop
Monday, Feb. 24 – Tuesday, Feb. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
You are unique, and if that is not fulfilled, then something has been lost.
Martha Graham, American dancer and ...Learn More


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In the News
Cutting-Edge Device Could Reverse Damage Caused by Heart Disease
By: James Walsh | November 2013

Sunshine Heart's C-Pulse device, which could reverse heart damage in some patients, has a potential worldwide market of up to $1 billion, an analyst says.

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New Medical Technologies Offer Hope for Sleep Apnea
By: Karen Weintraub | November 2013

Sleep apnea affects an estimated 5% to 10% of Americans and is undiagnosed in most of them. It can also lead to obesity, diabetes, high blood pressure, strokes and heart attacks. 

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Pacemaker May Help Arizona Boy Breathe Without a Ventilator
By: Angela Gonzales | November 2013

Phoenix Children's Hospital is conducting a new treatment because doctors listened to a patient’s mom.

 
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Despite Downturn in Pace of Startups, Med Tech Entrepreneurs Optimistic
By: Chris Arnold | October 2013

Since the financial crisis hit five years ago, there aren't as many Americans starting new businesses. In uncertain economic times, it's harder for entrepreneurs and investors to take the risk.  

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