Media Contact

News

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

SmartBrief
Chembio secures HHS contract to develop Zika test
Chembio Diagnostics has received a $5.9 million initial contract from HHS' Biomedical Advanced Research and Development ...Learn More
Abbott faces lawsuit from Alere over pending $5.8B merger
Alere has filed a lawsuit alleging Abbott Laboratories failed to promptly meet regulatory requirements -- including ...Learn More
Medtronic to cut back on some heart failure R&D to support HeartWare
Medtronic intends to reduce some of its research and development programs directed at heart failure to cover the cash burn ...Learn More
Bluedrop Medical obtains about $670K in funding round
A round of funding has brought in about $670,000 for Ireland-based startup Bluedrop Medical, which plans to use the money to ...Learn More
VP of regulatory affairs, quality assurance named by Sunshine Heart
Megan Brandt has been tapped to serve as vice president of regulatory affairs and quality assurance at Sunshine Heart, a new ...Learn More
Report predicts growth for global orthopedic implants market
A Grand View Research report predicts the worldwide market of orthopedic implants will reach $6.2 billion by 2024 due to ...Learn More
Hospital becomes first to use Edwards' heart valve since FDA approval
PinnacleHealth is the first hospital system to use Edwards Lifesciences' Edwards Intuity Elite valve for patients with ...Learn More
Combined angiography system debuted by Getinge, GE Healthcare
A combined angiography system intended for a wider range of surgical procedures and interventions in hybrid operating rooms ...Learn More
UK regulator updates guidance on apps, software as medical devices
An updated guidance has been released by the UK's Medicines and Healthcare products Regulatory Agency to clarify whether ...Learn More
HeartFlow's cardiac imaging platform gains NICE support
The UK's National Institute for Health and Care Excellence has endorsed the use of HeartFlow's cardiac imaging platform for ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
Like integrity, love of life was not a subject to be studied, it was a contagion to be caught. And you had to catch it from someone who had it.
...Lois McMaster Bujold, writer
Earlybird fund to invest up to $135M in medtech, diagnostics companies
The Earlybird Health Tech Fund, with a target size of up to about $135 million, has been launched by venture capital firm ...Learn More
Funding round pulls in $6M for Gobiquity
A round of Series B financing led by InterWest Partners has brought in $6 million for Gobiquity, maker of the GoCheck Kids ...Learn More
Rivanna Medical obtains $3M in funding round
A round of equity funding involving unnamed investors has pulled in $3 million for Charlottesville, Va.-based Rivanna ...Learn More
Offering could bring in $2.3M for MBio Diagnostics
A public offering of stock and warrant units could bring in $2.3 million for MBio Diagnostics, according to a filing with ...Learn More
CTL Medical, Firehouse Medical reach GSA partnership
A General Services Administration partnership has been reached by Dallas-based CTL Medical and Firehouse Medical, a ...Learn More
Baxter, Satellite Healthcare reach dialysis care partnership
Baxter International's Amia Automated Peritoneal Dialysis system will be offered by Satellite Healthcare to its peritoneal ...Learn More
Study shows positive results for InSightec's focused ultrasound system
A 76-patient study in the New England Journal of Medicine showed positive results for InSightec's ExAblate Neuro focused ...Learn More
Ethicon, Touch Surgery team up on surgical simulation app
A free mobile app that offers training on over 75 simulated surgical procedures has been developed through a partnership ...Learn More
Warning on programmable syringe pumps issued by FDA
A safety notice was issued by the FDA to health care providers about serious clinical consequences of therapy delay, ...Learn More
FDA clears post-dermal procedure device from Oculus
The FDA has given Petaluma, Calif.-based Oculus Innovative Sciences 510(k) clearance for its post-dermal procedure device ...Learn More
West Coast Diagnostics Summit
Nov. ...Learn More
The greater part of our happiness or misery depends upon our dispositions, and not upon our circumstances.
...Martha Washington, US first lady
Texas venture capital firm gets $75M boost for medtech, software fund
Austin, Texas-based S3 Ventures has secured $75 million for its sixth venture capital fund dedicated to local medtech and ...Learn More
US antitrust waiting period cleared by LabCorp for Sequenom purchase
LabCorp said Monday the required waiting period under US antitrust regulations has ended for its pending acquisition of ...Learn More
Canadian biotech firm acquired by Earth Science Tech
Boca Raton, Fla.-based Earth Science Tech said it acquired the majority of assets and business of BEO-ITS, a Canadian ...Learn More
Coloplast to expand workforce in US headquarters
Denmark-based Coloplast is looking to significantly expand its US operations with the addition of new employees at its ...Learn More
Global smart wearable health care devices, services market poised for growth
A Technavio report predicts the worldwide market for smart wearable health care devices and services will see a compound ...Learn More
Research firm predicts growth for global microbiology testing market
The worldwide microbiology testing market is expected to hit $5.77 billion by 2021 with an 11.5% compound annual growth rate ...Learn More
Trial begins for SRS Medical's temporary prostatic stent
The first patients in an FDA investigational device exemption study of the Spanner temporary prostatic stent have been ...Learn More
Edible, melanin-based battery introduced by scientists for medical devices
A digestible, non-toxic battery that can power 5-milliwatt ingestible medical devices for up to 18 hours has been unveiled ...Learn More
Bio2 Medical's embolism protection catheter cleared by FDA
The FDA has given Golden, Colo.-based BiO2 Medical 510(k) clearance for its Angel Catheter, a device that traps clinically ...Learn More
FDA clears expanded sizes of Amedica's interbody fusion device
Amedica has secured clearance from the FDA to market additional sizes of its Valeo II Lateral Lumbar device, which is ...Learn More
FDA Submissions Strategy Workshop
Oct. ...Learn More
That is the true perfection of man, to find out his imperfections.
...St. Augustine, philosopher and theologian
Deal to acquire HeartWare finalized by Medtronic
Medtronic has wrapped up its acquisition of HeartWare International. ...Learn More
Lombard Medical leaves US, considers sale
Lombard Medical Technologies on Monday said it pulled its sales force from the US and transferred most of its commercial ...Learn More
OraSure secures BARDA contract for Zika test development
OraSure Technologies has received a six-year, multiphased contract from HHS' Biomedical Advanced Research and Development ...Learn More
Study: After FDA warning, power morcellator use drops in US
The US rate of minimally invasive hysterectomies performed with power morcellators was 3% in 2015, down from almost 14% in ...Learn More
Siemens Healthineers North America names new SVP
Terry Coutsolioutsos, who has 25 years of medical device industry experience, has been tapped to serve as senior vice ...Learn More
First procedure using St. Jude Medical defibrillator recorded
The Golden Jubilee National Hospital in Scotland was the first to perform a procedure using St. ...Learn More
Study shows positive results for Abbott Vascular's drug-eluting stent
A study in Catheterization and Cardiovascular Interventions showed positive results for Abbott Vascular's Xience V ...Learn More
Next-gen blood glucose-monitoring system debuted by Roche unit
The Accu-Chek Guide, a next-generation blood glucose-monitoring system that connects to the Accu-Chek Connect diabetes ...Learn More
Medical device industry reaches deal with FDA on user fee program
The medical device industry has agreed with the FDA to pay $999.5 million under the agency's new five-year user fee program ...Learn More
Final guidances related to benefit-risk determinations released by FDA
A final guidance has been issued by the FDA to outline the factors the agency takes into consideration when making ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
Sept. 27-28 | Washington, D.C. ...Learn More
To love oneself is the beginning of a lifelong romance.
...Oscar Wilde, writer
Rio Grande Neurosciences terminates agreement to be acquired by Endonovo
Endonovo said it will not proceed with its $22 million acquisition of Rio Grande Neurosciences after its binding letter of ...Learn More
Private placement pulls in $13.75M for ViewRay
A private placement of about 4.6 million units of stock and warrants has brought in $13.75 million for ViewRay. ...Learn More
EU awards Dune Medical $3.4M grant for biopsy device development
The European Commission has given Dune Medical a grant worth about $3.4 million to develop a biopsy device that is based on ...Learn More
Patricia Industries reaches deal to buy LABORIE
Sweden-based Patricia Industries has agreed with Audax Private Equity to acquire Canada-based LABORIE, a developer of ...Learn More
Purchase of Neoptics' assets finalized by Presbia unit
The purchase of assets from Swiss firm Neoptics, maker of the Icolens implantable device for presbyopia, has been completed ...Learn More
Report: Global orthopedic devices market poised for growth
A Market Research Engine report predicts the worldwide market for orthopedic devices will hit $47.5 billion by 2020 with a ...Learn More
Deep brain stimulation could help brain trauma patients, but the technology needs a boost
Someone suffers from a brain injury every 15 seconds in the US. Some injuries are concussions while others are worse. ...Learn More
First implantations using abdominal stent graft system recorded by Endologix
Two patients at the Auckland City Hospital in New Zealand were the first to undergo implantations using Endologix's Ovation ...Learn More
Knotless sutures debuted by Ethicon
The Stratafix Spiral PDS Plus and Stratafix Spiral Monocryl Plus Knotless Tissue Control devices have been launched by ...Learn More
AdvaMed comments on FDA's guidance on patient-specific device data sharing
AdvaMed has submitted comments to the FDA concerning the agency's guidance on how medical device makers can share ...Learn More
FDA permits ImPACT to market devices for post-concussion cognitive testing
ImPACT Applications has obtained permission from the FDA to market its Immediate Post-Concussion Assessment and Cognitive ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Rio Grande Neurosciences terminates agreement to be acquired by Endonovo
Endonovo said it will not proceed with its $22 million acquisition of Rio Grande Neurosciences after its binding letter of ...Learn More
Private placement pulls in $13.75M for ViewRay
A private placement of about 4.6 million units of stock and warrants has brought in $13.75 million for ViewRay. ...Learn More
EU awards Dune Medical $3.4M grant for biopsy device development
The European Commission has given Dune Medical a grant worth about $3.4 million to develop a biopsy device that is based on ...Learn More
Patricia Industries reaches deal to buy LABORIE
Sweden-based Patricia Industries has agreed with Audax Private Equity to acquire Canada-based LABORIE, a developer of ...Learn More
Purchase of Neoptics' assets finalized by Presbia unit
The purchase of assets from Swiss firm Neoptics, maker of the Icolens implantable device for presbyopia, has been completed ...Learn More
Report: Global orthopedic devices market poised for growth
A Market Research Engine report predicts the worldwide market for orthopedic devices will hit $47.5 billion by 2020 with a ...Learn More
Deep brain stimulation could help brain trauma patients, but the technology needs a boost
Someone suffers from a brain injury every 15 seconds in the US. Some injuries are concussions while others are worse. ...Learn More
First implantations using abdominal stent graft system recorded by Endologix
Two patients at the Auckland City Hospital in New Zealand were the first to undergo implantations using Endologix's Ovation ...Learn More
Knotless sutures debuted by Ethicon
The Stratafix Spiral PDS Plus and Stratafix Spiral Monocryl Plus Knotless Tissue Control devices have been launched by ...Learn More
AdvaMed comments on FDA's guidance on patient-specific device data sharing
AdvaMed has submitted comments to the FDA concerning the agency's guidance on how medical device makers can share ...Learn More
FDA permits ImPACT to market devices for post-concussion cognitive testing
ImPACT Applications has obtained permission from the FDA to market its Immediate Post-Concussion Assessment and Cognitive ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Far away there in the sunshine are my highest aspirations. I may not reach them, but I can look up and see their beauty, believe in them, and try to follow where they lead.
Louisa May Alcott, ...Learn More
Garwood Medical Devices advances funding round
A round of Series A funding has brought in $2 million for Buffalo, N.Y.-based Garwood Medical Devices, bringing the company ...Learn More
Life sciences, tech fund secures $98.6M in private placement
A private placement has pulled in about $98.6 million for Cambridge Innovation Capital, a fund dedicated to life sciences ...Learn More
Purchase of ETE Medical, subsidiaries finalized by Confluent
The acquisition of ETE Medical and its units Biomedical Structures, a maker of biomedical textile implants, and Modified ...Learn More
Report predicts growth for Japanese orthopedic devices market
The Japanese market for orthopedic devices remains poised for growth, with its largest segment, the hand and wrist device ...Learn More
Getinge dismisses CEO, appoints acting chief
Alex Myers has been let go from his position as CEO of Swedish medtech company Getinge due to strategy differences. ...Learn More
RenovaCare creates stem cell suspension device for burn injuries
An experimental hand-held device called SkinGun, which takes about 90 minutes to spray stem cells on burn injuries to ...Learn More
Next-gen heated humidification system unveiled by Fisher & Paykel
The F&P 950 Heated Humidification System, designed to provide support for noninvasive, invasive and Optiflow nasal high flow ...Learn More
FDA clears respiratory viral test from Alere
The FDA has granted Alere 510(k) clearance for its Alere i RSV test, which is intended for detecting respiratory syncytial ...Learn More
Accelerator for Ion Beam Applications' proton therapy system cleared by FDA
Ion Beam Applications has obtained clearance from the FDA for a superconducting accelerator for its Proteus One, an ...Learn More
EU OKs Masimo's single-use acoustic respiration sensor
European regulators have given Masimo CE mark approval for its RAS-45, a single-use acoustic respiration sensor intended for ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
If you have knowledge, let others light their candles at it.
Mark Rowse, ...Learn More
Square 1 Bank provides $10M credit line to ReVision Optics
A credit facility worth $10 million has been secured by Lake Forest, Calif.-based ReVision Optics from Square 1 Bank, a ...Learn More
Microbot merges with StemCells
Microbot, an Israel-based maker of miniature robots that can be used for cleaning artificial drainage pipes inside the body, ...Learn More
NLT Spine to be acquired by SeaSpine
A definitive agreement has been reached by Carlsbad, Calif.-based SeaSpine to acquire Israel-based medical device maker NLT ...Learn More
Becton Dickinson commits $20M to Utah facility expansion
Becton Dickinson said it will invest $20 million in the expansion of its Sandy, Utah, facility, which manufactures blood ...Learn More
Report predicts growth for US implantable medical devices market
A Transparency Market Research report predicts the US market for implantable medical devices will reach $73.94 billion by ...Learn More
Report: Worldwide spinal implants, devices market poised for growth
A Grand View Research report predicts the global market for spinal implants and spinal devices will reach $19.54 billion by ...Learn More
Medtronic releases warning, updates instructions on EnVeo R delivery system use
Medtronic has released a letter alerting doctors to take caution when using its minimally invasive EnVeo R delivery system ...Learn More
App for continuous positive airway pressure mask users debuted by ResMed
The myAir app, intended to improve adherence of patients with sleep apnea who use continuous positive airway pressure masks, ...Learn More
FDA OKs expanded indication for Edwards Lifesciences' heart valves
The Sapien XT and Sapien 3 heart valves from Edwards Lifesciences, previously approved for use in patients at high risk for ...Learn More
Electrical fault risk prompts recall of HeartWare's implantable heart pumps
HeartWare International has pulled an unspecified number of its HVAD implantable heart pumps with serial numbers preceding ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
If we are to achieve a richer culture, rich in contrasting values, we must recognize the whole gamut of human potentialities, and so weave a less arbitrary social fabric, one in which each diverse gift will find a fitting place.
Margaret Mead, cultural ...Learn More
Report: Top medtech firms transitioning to service offerings
A PwC Health Research Institute report shows leading medtech companies, including Medtronic, Stryker and Zimmer Biomet, are ...Learn More
B. Braun completes integration of pump with Epic's EMR system
AngioDynamics seeks more workers for N.Y. manufacturing line
AngioDynamics is looking to hire 25 more workers for its angiographic catheter manufacturing line at its Queensbury, N.Y., ...Learn More
Trovagene liquid biopsy tests gain insurance coverage
Blue Cross Blue Shield of Illinois has agreed to cover the use of Trovagene's full line of Trovera liquid biopsy tests. ...Learn More
New president, CEO named by Alphaeon
Murthy Simhambhatla, former president of Abbott Medical Optics, has been tapped to serve as president and CEO of Alphaeon. ...Learn More
New CFO named by Valeritas
Erick Lucera, who has more than 20 years of experience in medtech, biotech and specialty pharmaceutical investment and ...Learn More
Trial of InVivo's neuro-spinal scaffold yields improvement in another patient
Another patient in a trial of InVivo Therapeutics' neuro-spinal scaffold has demonstrated signs of improvement using the ...Learn More
Barrier membrane for oral surgery debuted by Citagenix
The Neomem FlexPlus, a single-layer collagen membrane, has been launched by Antibe Therapeutics' subsidiary Citagenix. ...Learn More
Senate bill would strengthen safeguards for contact lens sales
Sens. ...Learn More
FDA: Custom Ultrasonics' reprocessors still not to be used for duodenoscopes
The use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors in cleaning duodenoscopes is still not ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
April 25-26, 2017 | Washington, D.C. ...Learn More
I have learned over the years that when one's mind is made up, this diminishes fear.
Rosa Parks, civil rights ...Learn More
Rotation Medical gets $12M boost
An additional $12 million was raised by Plymouth, Minn.-based Rotation Medical in a Series B funding round extension. ...Learn More
Funding boost secured by Oculis
A round of Series A financing has brought in an unspecified amount for ophthalmological developer Oculis. ...Learn More
Funding round brings in $5.2M for ProteoMediX
A round of equity financing led by Altos Venture has pulled in about $5.2 million for Swiss diagnostics company ProteoMediX. ...Learn More
CS Medical, GE Healthcare reach distribution deal
GE Healthcare has agreed to distribute CS Medical's TD 100 automated transesophageal echocardiography ultrasound probe ...Learn More
Permanent CEO named by Cardiovascular Systems
Scott Ward, who has been serving as interim CEO of Cardiovascular Systems, was appointed to the position permanently. ...Learn More
Report predicts growth for global medical device funding
A CB Insights report predicts the global medical device industry will see more than 475 venture capital deals by the end of ...Learn More
Study shows positive results for Intuitive Surgical's robotic surgical system
A study in the journal Surgical Endoscopy showed positive results for Intuitive Surgical's da Vinci robotic surgical system. ...Learn More
Spinal Simplicity unveils next-gen fusion device
The next-generation Minuteman G3 fusion device has been introduced by Spinal Simplicity. ...Learn More
FDA OKs ablation catheter from Biosense Webster
The FDA has given Johnson & Johnson subsidiary Biosense Webster premarket approval for its Thermocool SmartTouch SF ...Learn More
Arineta's cardiac mapping CT device cleared by FDA
The SpotLight CT scanner, developed by Israel-based Arineta, has obtained 510(k) clearance from the FDA. ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
A lot of people are afraid to say what they want. That's why they don't get what they want.
Madonna, ...Learn More
Del. biotech startup acquired by Zimmer Biomet
Zimmer Biomet has acquired Delaware-based biotechnology startup CD Diagnostics for undisclosed terms. ...Learn More
Mazor Robotics gets $20M boost from Medtronic
The second tranche of equity investment by Medtronic in Mazor Robotics, valued at $20 million, has been completed following ...Learn More
Qiagen announces share repurchase plan to return $250M to shareholders
Qiagen has announced a synthetic share repurchase proposal through which it intends to return about $250 million to ...Learn More
Insightec, Siemens reach collaborative strategic deal
Insightec and Siemens Healthineers have agreed to collaborate on the development of compatibility between Siemens Magnetom ...Learn More
CMS to cover use of Exact Sciences' colon cancer test every 3 years
Exact Sciences' Cologuard colon cancer test will receive Medicare Advantage coverage every three years without patient cost ...Learn More
President, CEO to retire from RTI Surgical
Brian Hutchison will retire as president, CEO and member of board of directors at Florida-based RTI Surgical. ...Learn More
A look at the industrial sterilization market
When choosing the right sterilization method to use, there are two questions that need to be answered: "What method(s) will ...Learn More
Study shows positive results for EnteroMedics' weight loss system
A study in the journal Obesity Surgery showed positive results for EnteroMedics' Maestro Rechargeable System as a ...Learn More
New version of laparoscopic procedure system debuted by Teleflex
The second-generation Percuvance Percutaneous Surgical System has been launched by Teleflex for use in percutaneous ...Learn More
AdvaMed comments on FDA's draft guidance on 3D printing
AdvaMed has submitted comments to the FDA concerning the agency’s guidance on 3D printing, including the recommendation that ...Learn More
Valve system from Edwards Lifesciences wins FDA nod
Edwards Lifesciences has obtained approval from the FDA for its Edwards Intuity Elite valve system, a rapid deployment ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
Wearable Devices Webinar: Regulatory and Litigation Risks
Sept. 15 | Virtual 1:00 p.m.-2:00 p.m. ...Learn More
It is our choices ... that show what we truly are, far more than our abilities.
J.K. Rowling, ...Learn More
US fund invests $2.5M in Australian medtech startup
Global Health Investment Fund, a US-based joint venture formed by the Gates Foundation and J.P. ...Learn More
Funding round pulls in $2.1M for Pursuit Vascular
A round of debt financing involving 31 unnamed sources has brought in $2.1 million for Maple Grove, Minn.-based Pursuit ...Learn More
New vice president of R&D named by ReVision Optics
Nick Manesis, former vice president of research and development at Allergan, has been tapped to serve as vice president of ...Learn More
Report predicts growth for global neuromodulation devices market
A Transparency Market Research report predicts the worldwide market for neuromodulation devices will hit $7.07 billion by ...Learn More
Global medical electronics market poised for growth, report says
A Global Market Insights report predicts the worldwide medical electronics market will reach $60 billion by 2023 with a 5.5% ...Learn More
Data show positive results for Fractyl's duodenal mucosal resurfacing device
First-in-human data from a 30-patient study published in Diabetes Care showed positive results for Fractyl Laboratories' ...Learn More
Bonesupport's antibiotic-eluting bone substitute gets IDE from FDA
The FDA has given Swedish company Bonesupport an investigational device exemption to conduct a 230-patient study of its ...Learn More
Apple seeks patent for heart activity-tracking wearable device
An application for a US patent has been submitted by Apple for a wearable device that uses multiple sensors to monitor ...Learn More
Femoral nail system debuted by Orthopaedic Implant
The Antegrade/Retrograde Intramedullary Femur Nail System has been launched by Reno, Nev.-based Orthopaedic Implant for ...Learn More
Guidances on 510(k) submissions for electrosurgical devices finalized by FDA
Two final guidances have been issued by the FDA outlining its recommendations for device descriptions, substantial ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
Cybersecurity Summit
Nov. ...Learn More
Take up one idea. Make that one idea your life -- think of it, dream of it, live on that idea. Let the brain, muscles, nerves, every part of your body, be full of that idea, and just leave every other idea alone. This is the way to success.
Swami Vivekananda, monk and ...Learn More
ForSight Vision5 to be acquired by Allergan
Allergan has agreed to pay $95 million plus potential milestone payments to acquire ForSight Vision5, maker of the Helios ...Learn More
Follow-on offering could bring in $30M for Avinger
A follow-on offering of shares has been priced by Redwood City, Calif.-based Avinger in hopes of raising $30 million. ...Learn More
Funding round pulls in $15M for Metabolon
A round of Series E financing involving Essex Woodlands has brought in $15 million for Durham, N.C.-based Metabolon, which ...Learn More
Mallinckrodt enters deal to buy Wis. regenerative medicine firm
Mallinckrodt has reached an agreement to acquire Wisconsin-based regenerative medicine firm Stratatech, which develops the ...Learn More
IBM, Hangzhou CognitiveCare to bring oncology software to China
A partnership deal has been reached by IBM and Hangzhou CognitiveCare to provide 21 hospitals across China with IBM's Watson ...Learn More
Report predicts growth for global connected wearables, health devices market
A Grand View Research report predicts the worldwide market for remote patient monitoring systems and wearable medical ...Learn More
Study shows positive results for Spectranetics' drug-coated balloon
A study presented at the Amputation Prevention Symposium showed positive results for Spectranetics' Stellarex drug-coated ...Learn More
Exact Sciences' colon cancer test wins reimbursement from 2 insurers
Health Care Service Corp. ...Learn More
Insulin management system from Medtronic debuted in US
The MiniMed 630G insulin management system has been launched by Medtronic in the US for use with Ascensia Diabetes Care's ...Learn More
EU OKs FlowAid Medical's sequential contraction compression device
European regulators have given FlowAid Medical CE mark approval for its FA100 SCCD sequential contraction compression ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
People will always try to stop you doing the right thing if it is unconventional.
Warren Buffett, businessman, investor and ...Learn More
Torax Medical closes $25M funding round
Torax Medical, a maker of devices for treating fecal incontinence and gastroesophageal reflux disease, has closed its round ...Learn More
Texas Medical Center accelerator welcomes 11 medtech startups
Texas Medical Center's Innovation Institute has chosen 11 medical device startups to join a 15-week program of its TMCx ...Learn More
Domain Surgical acquired by OmniGuide
Domain Surgical, which develops the FMX Ferromagnetic Surgical System for soft-tissue cutting and coagulation, has been ...Learn More
Offering of Zimmer Biomet shares could pull in $965.4M
A secondary offering of more than 7.4 million shares of common stock has been announced by Zimmer Biomet in hopes of raising ...Learn More
Medicrea obtains more than $22M in financing agreements
An equity private placement and an offering of convertible bonds have brought in about $22.35 million for Medicrea, which ...Learn More
Funding round brings in $8M for Rotation Medical
A round of financing has pulled in $8 million for Plymouth, Minn.-based Rotation Medical, according to a filing with the ...Learn More
Cigna to cover ConfirmMDx prostate cancer test
Cigna will cover MDxHealth's ConfirmMDx, an epigenetic tissue-based test intended to rule out false-negative biopsy results ...Learn More
Interbody device, lateral access system debuted by Spine Wave
The XLR II Lateral Access System and the Velocity L Expandable Interbody Device have been launched by Shelton, Conn.-based ...Learn More
Hammertoe correction device from Centric Medical cleared by FDA
The FDA has granted Centric Medical 510(k) clearance for its Hammertoe Correction System, a dual-threaded, foot-phalange ...Learn More
EU OKs drug-coated balloon catheter from Spectranetics
European regulators have given Colorado Springs, Colo.-based Spectranetics CE mark approval for its AngioSculptX Drug-coated ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
There is no easy walk to freedom anywhere, and many of us will have to pass through the valley of the shadow of death again and again before we reach the mountaintop of our desires.
Nelson Mandela, activist and political ...Learn More
Sunshine Heart acquires Baxter's fluid filtration device
A deal has been reached by Eden Prairie, Minn.-based Sunshine Heart to acquire Baxter's Aquadex fluid filtration device, ...Learn More
Alere comments on pending merger with Abbott
Alere said Abbott should not suggest that Alere will not proceed with the companies' pending $5.8 billion merger because ...Learn More
Presbia unit to pay about $1.5M for Neoptics assets
Presbia's Ireland-based subsidiary has agreed to purchase certain assets from Swiss firm Neoptics, maker of the Icolens ...Learn More
New board member named by Helius Medical
Thomas Griffin, vice president of finance at Entellus Medical, has been tapped to serve on the board of directors at Helius ...Learn More
New chief commercialization officer named by Bionik
Timothy McCarthy, former CEO of Medical Compression Systems, has been tapped to serve as chief commercialization officer at ...Learn More
Scientists create retina imaging device for children
A lightweight, hand-held device has been developed by researchers from Duke University to facilitate high-resolution retina ...Learn More
Midvolume coagulation analyzer debuted by Siemens
The Sysmex CS-2500 System, a midvolume coagulation analyzer, has been launched by Siemens Healthineers' Laboratory ...Learn More
Boston Scientific's S-ICD system wins FDA nod
The FDA has granted Boston Scientific approval for its Emblem MRI Subcutaneous Implantable Defibrillator System and has ...Learn More
Accuray's treatment delivery platform gets EU approval
European regulators have given Accuray CE mark approval for its Radixact treatment delivery platform, which includes the ...Learn More
EU OKs large-bore vascular closure device from InSeal
European regulators have given InSeal Medical CE mark approval for its InClosure VCD, a large-bore vascular closure device ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
There is no education like adversity.
Benjamin Disraeli, political leader and ...Learn More
CVRx gets $93M in venture funding for clinical trial of heart failure device
CVRx, maker of the Barostim Neo implant to treat chronic heart failure, has raised $93 million in venture capital in a ...Learn More
Funding round pulls in $5.9M for Check-Cap
A direct placement of shares and warrants with an institutional investor has brought in $5.9 million for Check-Cap. ...Learn More
Fe3 Medical gets $3.5M boost
Texas' government has invested $3.5 million in the Series B funding round of Fe3 Medical, a startup from San Antonio-based ...Learn More
ElectroCore obtains $1.5M in funding round
A round of debt financing has pulled in $1.5 million for ElectroCore, according to a filing with the SEC. ...Learn More
Aetna to cover Neuronetics' depression therapy system
Aetna has agreed to cover Neuronetics' NeuroStar TMS Therapy, a system that provides noninvasive treatment for major ...Learn More
New CFO named by Seno Medical Instruments
Eric Davis has been tapped to serve as chief financial officer at Seno Medical Instruments, maker of the Imagio OA breast ...Learn More
Secrets of a CMO: What CardioFocus and Minnetronix learned over 16 years of partnership
In the beginning, Minnetronix had no idea what CardioFocus' probability of success was, but over time, their contract has ...Learn More
Camber to conduct study of sacroiliac joint fusion implant
Camber Spine Technologies, in partnership with Dr. ...Learn More
Medtronic's software for deep brain stimulation wins EU approval
European regulators have given Medtronic CE mark approval for its SureTune2 software for use in devices that facilitate deep ...Learn More
FDA seeks comments on balancing premarket, postmarket data collection
All medical devices approved before 2010 through a premarket approval application have been reviewed by the FDA's Center for ...Learn More
FDA panel to consider risk classifications for wound-care devices
The FDA's General and Plastic Surgery Devices Panel will meet Sept. ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
Character cannot be developed in ease and quiet. Only through experience of trial and suffering can the soul be strengthened, vision cleared, ambition inspired, and success achieved.
Helen Keller, writer and political ...Learn More
Smith & Nephew concludes $350M gynecology unit sale to Medtronic
Smith & Nephew said today that the sale of its gynecology unit to Medtronic, valued at $350 million, has been completed. ...Learn More
DOD taps J&J unit for $60M supply contract
The Department of Defense has awarded Johnson & Johnson Health Care Systems a five-year ...Learn More
Mirabilis Medica obtains $5M in funding round
A round of debt financing involving three anonymous sources has brought in $5 million for Mirabilis Medica, according to a ...Learn More
Medtronic deal makes Mazor CEO bullish about sales, utilization
Mazor Robotics CEO Ori Hadomi said the rest of 2016 will be a "record year" for the company's system sales and utilization, ...Learn More
TransEnterix to concentrate on winning FDA approval for ALF-X robot
TransEnterix intends to prioritize securing FDA approval for its CE-marked ALF-X robot, company executives said last week in ...Learn More
Chinese patent issued to Analytica for pelvic floor force sensing device
The PeriCoach, a pelvic floor force sensing device from Analytica, has obtained patent protection in China. ...Learn More
Emperra unveils Bluetooth-connected insulin pen
The Emperra ESYSTA BT, an insulin pen that documents insulin injections and transmits data to an app using Bluetooth ...Learn More
Ultrasound scanner debuted by Signostics
Signostics has launched its Uscan ultrasound scanner intended for use in urological catheter placement, kidney exams, ...Learn More
Draft guidances on 510(k) device modifications released by FDA
Two draft guidances have been issued by the FDA updating its policy on when modifications to an existing medical device or ...Learn More
South Korea OKs Viveve's system for postpartum vaginal laxity
South Korea's Ministry of Food and Drug Safety has given Viveve approval for its Viveve System, a nonsurgical treatment for ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
Sept. 28-29 | Washington, D.C. ...Learn More
Any fool can criticize, condemn and complain -- and most fools do. But it takes character and self-control to be understanding and forgiving.
Dale Carnegie, writer, lecturer and leadership ...Learn More
Funding round brings in $21.3M for Osprey Medical
A sale of CHESS depository interests has brought in $21.3 million for Australia-based Osprey Medical. ...Learn More
AdvaMed chairman-elect discusses medtech challenges
Nadim Yared, chairman-elect of AdvaMed, talks about the capital-formation challenges in the medtech space in this interview, ...Learn More
Myriad invests in neuroscience with Assurex acquisition
Myriad Genetics is gaining access to Assurex Health's commercial neuroscience diagnostic test GeneSight in an acquisition ...Learn More
Financing round pulls in $20M for Ornim
A round of Series C financing led by LongTec HongTao China Ventures has brought in $20 million for Israeli firm Ornim. ...Learn More
GE, Check-Cap reach X-ray capsule manufacturing partnership
A deal has been reached by GE Healthcare and Israel-based diagnostics firm Check-Cap to create and validate X-ray source ...Learn More
Vice president of sales worldwide named by ReVision Optics
Frank Shields has been tapped to serve as vice president of sales worldwide at ReVision Optics, a new position in the ...Learn More
NuVasive scores reimbursement win for growth modulation rod
NuVasive has obtained New Technology Add-On Payment coverage from the CMS for its MAGEC system, a magnetically controlled ...Learn More
Study shows positive results for Penumbra's next-gen stent retriever
A 198-patient, 25-site study presented at the Society of NeuroInterventional Surgery Annual Meeting showed positive results ...Learn More
FDA clears imaging software system from EndoChoice
EndoChoice has obtained clearance from the FDA for its Lumos imaging software system, which features two settings that allow ...Learn More
EU OKs pediatric indication for Masimo's regional oxymetry system
European regulators have given Masimo CE mark approval for its O3 regional oxymetry with the O3 pediatric sensor for use in ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
Oct. ...Learn More
Character, not circumstances, makes the man.
Booker T. Washington, educator, writer and ...Learn More
Thermo Fisher to offer about $669M in senior notes
An offering of senior notes due in 2018 could bring in about $669 million for Thermo Fisher Scientific, according to a ...Learn More
Saudi Arabia taps Covalon for $7.6M wound dressing supplies contract
Saudi Arabia's Ministry of Health has awarded Covalon Technologies a 12-month supply contract, valued at $7.6 million, for ...Learn More
Seed funding round pulls in $1.5M for iBeat
A round of oversubscribed seed funding has brought in $1.5 million for iBeat, an early-stage heart monitor developer based ...Learn More
Manufacturing facility launched by Alere in India
A 180,000-square-foot integrated manufacturing facility has been opened by Alere in India. ...Learn More
New chief medical officer named by Corindus
J. Aaron Grantham has been tapped to serve as chief medical officer at Corindus Vascular Robotics. ...Learn More
First procedure using arterial plaque removal device recorded by Avinger
A patient with peripheral artery disease in San Antonio was the first to undergo a three-pronged procedure using Avinger's ...Learn More
Fusion plate portfolio unveiled by Flower Orthopedics
The MTP Fusion Plate Portfolio has been launched by Flower Orthopedics for primary metatarsophalangeal joint arthritis and ...Learn More
Survey: Most device makers still unprepared for UDI compliance deadline
A survey from software firm Loftware and professional services company USDM Life Sciences shows only 15% of medical-device ...Learn More
FDA clears Luminex's PCR-based assay for respiratory pathogens
The FDA has given Luminex clearance for its ARIES Influenza A/B and Respiratory Syncytial Virus Assay for use on its ARIES ...Learn More
BTG's drug-eluting beads reclassified by EU
European regulators have reclassified BTG's DC Bead and DC Bead M1 as Class III medical devices. ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
Sept. 27-28 | Washington, D.C. ...Learn More
Success is most often achieved by those who don't know that failure is inevitable.
Coco Chanel, fashion ...Learn More
DOD taps Draeger for $57.4M medical supplies contract
The Department of Defense has awarded Draeger Medical a $57.4 million contract to provide the Army, Air Force, Marine Corps, ...Learn More
Bioventus drops plans to go public
A planned initial public offering aimed at raising $150 million has been withdrawn by Bioventus. ...Learn More
Pa. private equity fund secures $25M for life sciences industry
Velocity Fund Partners, a Pennsylvania-based private equity fund dedicated to medical devices, pharmaceuticals and ...Learn More
J&J's Codman Neuro, InNeuroCo reach exclusive distribution deal
Codman Neuro, a Johnson & Johnson unit, has agreed to exclusively distribute InNeuroCo's intermediate catheter in the US and ...Learn More
ImpediMed signs joint development deal with Mayo Clinic
A three-year deal has been signed by Australian medtech company ImpediMed and the Mayo Clinic to jointly create new ...Learn More
TransEnterix makes first sale of surgical robot
The first global sale of the ALF-X System, a surgical robot, has been made by TransEnterix to Humanitas Hospital in Milan, ...Learn More
First European implantation of pacemaker recorded by Biotronik
A patient at Great Western Hospital in Swindon, UK, was the first in Europe to be implanted with the Enitra 8 HF-T QP, a ...Learn More
Device for measuring fluid changes unveiled by ImpediMed
The Sozo platform, a device that uses electric currents to measure changes in body fluids to help manage chronic diseases ...Learn More
EU OKs ReliantHeart's left ventricular assist device
European regulators have given ReliantHeart CE mark approval for its aVAD, an intraventricular, axial flow left ventricular ...Learn More
Vascular stent from W. L. Gore gets FDA approval
The FDA has given W. L. ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
West Coast Diagnostics Summit
Nov. ...Learn More
A teacher affects eternity; he can never tell where his influence stops.
Henry Adams, ...Learn More
GSK to develop bioelectronic medicines with Verily Life Sciences
GlaxoSmithKline and Verily Life Sciences, Alphabet's life-sciences business, will form a $715 million joint venture called ...Learn More
Zimmer Biomet CEO details plans for long-term growth
Zimmer Biomet, which has recovered "top-line momentum" after its successful integration of Biomet, plans to sustain ...Learn More
Public offering could pull in $28M for Invuity
A public offering of 2.8 million shares has been priced by San Francisco-based Invuity, maker of the Eikon LT illuminated ...Learn More
Intuitive Surgical, Dextera Surgical reach joint development deal
A deal has been reached by Intuitive Surgical and Dextera Surgical to create stapler products for Intuitive's da Vinci ...Learn More
Quanterix signs license deal with Banyan Biomarkers
Quanterix and Banyan Biomarkers have reached a license agreement allowing Quanterix to develop the Banyan UCH-L1 and GFAP ...Learn More
2 new board members named by NuVasive
Mike O'Halleran and Pat Miles have been tapped to serve on the board of directors at NuVasive. ...Learn More
10 medtech startups to watch
Medical Design & Outsourcing chose 10 medtech startups to profile out of hundreds. ...Learn More
Essential Medical's vascular closure device gets IDE from FDA
The FDA has given Malvern, Penn.-based Essential Medical an investigational device exemption to conduct a 180-patient ...Learn More
App-connected health monitoring devices unveiled by Philips Healthcare
A line of health-monitoring devices has been launched globally by Philips Healthcare for people at risk for chronic ...Learn More
EU OKs intermediate-risk indication for Medtronic's heart valve system
European regulators have granted Medtronic CE mark approval for its CoreValve Evolut R system for use in treating patients ...Learn More
Supplemental PMA filing for steroid-releasing implant filed by Intersect ENT
Intersect ENT has filed a supplemental premarket approval application with the FDA for the use of its NOVA, an ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
3D Technology: What You Need to Know Now and for the Future
Oct. ...Learn More
Leadership is the capacity to translate vision into reality.
Warren Bennis, organizational ...Learn More
Boston Scientific to remain focused on internal R&D, CEO says
Boston Scientific plans to maintain its category leadership position through a continued focus on its internal research and ...Learn More
Public offering postponed by Bioventus
An initial public offering from Bioventus aimed at raising $150 million was postponed last week. ...Learn More
Ownership interest in CRO acquired by Global Center for Medical Innovation
An ownership interest in T3 Labs, a preclinical contract research organization, is being acquired from Emory/Saint Joseph's ...Learn More
Funding round pulls in $49M for VytronUS
A round of Series C equity financing has brought in $49 million for Sunnyvale, Calif.-based VytronUS. ...Learn More
Medical device startup partners with N.Y. institute, aims to create 40 jobs
Garwood Medical Devices, a Buffalo, N.Y.-based startup that develops devices for chronic wounds and joint-replacement ...Learn More
New chief commercial officer named by BrainScope
Andrew Holman, former president of corporate development at Greatbatch, has been tapped to serve as chief commercial officer ...Learn More
MIT scientists create portable biologic drug production device
A portable device that can manufacture a single dose of a biopharmaceutical drug on demand has been developed by researchers ...Learn More
Hand system unveiled by DePuy Synthes Trauma
The Variable Angle Locking Hand System, a platform of anatomically contoured and low-profile plates designed for treating ...Learn More
FDA clears Alcon's microstent system for primary open angle glaucoma
The FDA has given Novartis unit Alcon clearance for its CyPass microstent system, an implantable device intended for use ...Learn More
Micro Interventional's transapical access and closure device cleared by FDA
The FDA has granted Micro Interventional Devices clearance for its Permaseal, a transapical access and closure device that ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
FDA Submissions Strategy Workshop
Oct. ...Learn More
In all human affairs there are efforts, and there are results, and the strength of the effort is the measure of the result.
James Allen, ...Learn More
Auris Surgical, Hansen Medical complete $80M merger deal
The acquisition of intravascular robotics company Hansen Medical, valued at $80 million, has been completed by Auris ...Learn More
Public offering could pull in $151M for Exact Sciences
A public offering of 8.5 million shares of common stock has been priced by Exact Sciences in hopes of obtaining up to $151 ...Learn More
Tactile Systems obtains $40M in IPO
An initial public offering of 4 million shares has brought in $40 million for Tactile Systems Technology, a company that ...Learn More
Funding round pulls in $12M for nVision Medical
A round of Series B funding has brought in $12 million for nVision Medical, a maker of technologies for women's health. ...Learn More
First robotics-assisted total knee replacement recorded by Smith & Nephew
A patient at the John T. ...Learn More
Trial begins for Medtronic's directional atherectomy, drug-coated balloons
The first patients in a trial of directional atherectomy and drug-coated balloons, namely HawkOne, TurboHawk and In.Pact ...Learn More
EU OKs bionic vision system from Pixium Vision
European regulators have given Paris-based Pixium Vision CE mark approval to market its IRIS II bionic vision system for ...Learn More
SPR Therapeutics' peripheral nerve stimulation system cleared by FDA
The FDA has given SPR Therapeutics clearance to market its Sprint peripheral nerve stimulation system, a minimally invasive, ...Learn More
Canada OKs heart valve from Edwards Lifesciences
Edwards Lifesciences has obtained approval from Health Canada for its Edwards SAPIEN 3 heart valve, a device that comes in ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
Women's Executive Network: Driving Innovation in Tech and Leadership in Your Organization
Aug. ...Learn More
Far and away the best prize that life offers is the chance to work hard at work worth doing.
Theodore Roosevelt, 26th US ...Learn More
Mass. radiofrequency ablation firm acquired by Boston Scientific
Boston Scientific has agreed to pay an undisclosed amount to purchase Burlington, Mass.-based Cosman Medical, maker of ...Learn More
Alphatec's international business sold to Globus Medical for $80M
Musculoskeletal implant manufacturer Globus Medical has reached a deal to acquire Alphatec's international operations and ...Learn More
LabCorp to expand women's health offering with $371M Sequenom buyout deal
Sequenom has been acquired by the Laboratory Corp. ...Learn More
Tactile Systems lowers IPO target to $40M
Tactile Systems Technology is hoping to obtain $40 million in a planned initial public offering, down 33% from the proceeds ...Learn More
LabStyle Innovations becomes DarioHealth
Boston-based LabStyle Innovations is rebranding itself as DarioHealth to reflect its expansion into the mHealth and digital ...Learn More
Cohera Medical names new board member
Paul Thomas, the founder and CEO of Roka Bioscience, has been tapped to serve on the board of directors at Cohera Medical. ...Learn More
Study shows positive results for Baxter's high-flux dialyzer
A study in the American Society for Artificial Internal Organs Journal showed positive results for Baxter's Revaclear ...Learn More
Mobile digital radiography system unveiled by Virtual Imaging
The RadPro Mobile 40kW Flex Plus digital radiography system has been launched by Canon USA unit Virtual Imaging. ...Learn More
Expanded use of Tandem's insulin pump cleared by FDA
The t:slim insulin pump from Tandem Diabetes Care has received clearance from the FDA for an expanded indication and can now ...Learn More
Innovation in Leadership: Maximizing Diversity in Your Organization
Aug. ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
When you get into a tight place, and everything goes against you till it seems as if you couldn't hold on a minute longer, never give up then, for that's just the place and time that the tide'll turn.
Harriet Beecher Stowe, writer and ...Learn More
BioVentrix obtains $1.2M in funding round
An offering of convertible notes involving 12 anonymous investors has brought in $1.2 million for BioVentrix, according to a ...Learn More
Funding round pulls in $1M-plus for Intellirod Spine
A round of equity financing has pulled in over $1 million for Intellirod Spine. ...Learn More
Zimmer Biomet launches Signature Solutions for select hospitals
Zimmer Biomet on Tuesday announced the launch of Signature Solutions, a resource and analytics tool initially intended for ...Learn More
Xtant Medical to expand facility in Mont.
Xtant Medical on Tuesday said it is adding seven processing rooms to its tissue processing facility in Belgrade, Mont. ...Learn More
Q2 sales rise for St. Jude Medical
St. ...Learn More
Sight Sciences' viscosurgical system gets IDE from FDA
The FDA has given Sight Sciences an investigational device exemption to conduct a clinical study of its Visco 360 ...Learn More
Bone fragment therapy device to be unveiled by Medtronic in 10 countries
The VariLoc Locking Compression Plate System has been launched by Medtronic in China, with Pakistan, Lithuania, Greece, ...Learn More
FDA clears next-gen heartbeat monitor from BioTelemetry
Malvern, Pa.-based BioTelemetry has obtained clearance from the FDA to market its MCOT Patch, a next-generation mobile ...Learn More
Final guidance on adaptive design use released by FDA
A final guidance has been issued by the FDA outlining the advantages and proper implementation of adaptive designs in ...Learn More
FDA issues guidance on real-world data use for device regulatory decisions
Draft guidance has been released by the FDA providing clarification on the circumstances under which real-world data may be ...Learn More
Innovation in Leadership: Maximizing Diversity in Your Organization
Aug. ...Learn More
3D Technology: What You Need to Know Now and for the Future
Oct. ...Learn More
If you are not fired with enthusiasm, you will be fired with enthusiasm.
Vince Lombardi, ...Learn More
Torax Medical obtains $25M in funding round
A round of equity financing involving 17 anonymous sources has pulled in $25 million for St. ...Learn More
Medtronic expects $40B in free cash flow by 2021
Medtronic intends to generate free cash flow of $40 billion during the next five years, which will be used for bolt-on ...Learn More
Funding round pulls in $9M for Apama Medical
A round of equity funding involving 10 anonymous investors has brought in $9 million for Campbell, Calif.-based Apama ...Learn More
Streck signs exclusive supply deal with Biodesix
Streck has agreed to exclusively supply DNA and RNA tubes for molecular diagnostics firm Biodesix for undisclosed terms. ...Learn More
New CFO named by AngioDynamics
Michael Greiner has been tapped to serve as chief financial officer of Albany, N.Y.-based medical device firm AngioDynamics. ...Learn More
Infrared imaging technologies illuminate new capabilities in health care
The latest advances in near-infrared spectroscopy are enabling new capabilities in diagnosis and treatment, offering reduced ...Learn More
Trial begins for Bigfoot Biomedical's insulin delivery system
The first patients in a trial of the smartloop automated insulin delivery system have been enrolled by Milpitas, ...Learn More
Thrombectomy catheter debuted by Penumbra in US
The Ace68 Reperfusion Catheter has been launched by Penumbra in the US. ...Learn More
Draft guidance on UDI compliance issued by FDA
Draft guidance has been released by the FDA to help FDA-accredited issuing agencies and medical device labelers comply with ...Learn More
FDA panel backs moderate-complexity indication for Alere's diagnostic test
An FDA panel has recommended a proposal approving the use of Alere's Afinion HbA1c Dx test for diagnosing diabetes in ...Learn More
FDA clears Asuragen's qPCR-based assay for chronic myeloid leukemia
The FDA has given Austin, Texas-based Asuragen premarket clearance for its QuantideX qPCR BCR-ABL IS kit, which company ...Learn More
Innovation in Leadership: Maximizing Diversity in Your Organization
Aug. ...Learn More
FDA Submissions Strategy Workshop
Oct. ...Learn More
The superior man is modest in his speech but exceeds in his actions.
Confucius, ...Learn More
Direct Flow Medical obtains $27.1M in funding round
A round of equity and debt financing has brought in $27.1 million for Santa Rosa, Calif.-based Direct Flow Medical, bringing ...Learn More
InfoBionic gets $8.2M boost
A round of equity funding involving 55 anonymous sources has brought in $8.2 million for Lowell, Mass.-based InfoBionic, ...Learn More
Funding round pulls in $6.5M for nVision Medical
A round of equity financing involving 17 unnamed sources has pulled in $6.5 million for nVision Medical, according to a ...Learn More
Masimo opens manufacturing facility in Mexico
An assembly plant that could ultimately hire as many as 400 employees was opened by Irvine, Calif.-based Masimo in the ...Learn More
CFO to retire from Glaukos
Richard Harrison will retire as chief financial officer of Laguna Hills, Calif.-based Glaukos next year. ...Learn More
Study shows promising results for electroCore's nerve stimulation device
A 59-patient study in the journal Neurology showed promising results for a noninvasive vagus nerve stimulation device from ...Learn More
Nerve ablation system from Relievant Medsystems cleared by FDA
The INTRACEPT intraosseous nerve ablation system, developed by Redwood City, Calif.-based Relievant Medsystems to provide ...Learn More
Vasorum's vascular closure device wins FDA nod
The FDA has given Vasorum premarket approval for its Celt ACD vascular closure device, which is designed to close femoral ...Learn More
FDA clears assays from Inova Diagnostics
The FDA has granted San Diego-based Inova Diagnostics clearance for its QUANTA Flash dsDNA assay, which is intended for use ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
Leadership consists of nothing but taking responsibility for everything that goes wrong and giving your subordinates credit for everything that goes well.
Dwight D. Eisenhower, 34th US ...Learn More
J&J reaping benefits from device business restructuring, CEO says
Johnson & Johnson is progressing as planned six months after implementing a restructuring process for its orthopedics, ...Learn More
Offering pulls in $3.5M for Sunshine Heart
A direct offering of 3,468 shares of Series B convertible preferred stock has brought in $3.5 million for Eden Prairie, ...Learn More
Consensus Orthopedics obtains $1M in funding round
A round of equity financing has brought in $1 million for El Dorado Hills, Calif.-based Consensus Orthopedics, bringing the ...Learn More
Bovie Medical, Hologic reach sales channel partnership deal
Bovie Medical's J-Plasma product line will be added to Hologic's gynecological and gynecological/oncological surgery ...Learn More
J&J, Materialise team up on 3D-printed titanium craniofacial implants
A deal has been reached between Johnson & Johnson and Belgium-based 3D printing provider Materialise to create personalized ...Learn More
Varian Medical Systems to name imaging spinoff Varex Imaging
Varian Medical Systems' Imaging Components business will be named Varex Imaging upon completion of the division's spinoff by ...Learn More
LifeBond's Surgical Sealant Kit gets IDE from FDA
The FDA has given LifeBond an investigational device exemption to conduct a study of its LifeSeal Surgical Sealant Kit, ...Learn More
Study shows positive results for Accuray's radiation therapy system
A study in Anticancer Research: International Journal of Cancer Research and Treatment showed positive results for Accuray's ...Learn More
Multi-sinus dilation system released by Acclarent
The RELIEVA SCOUT Multi-Sinus Dilation System has been launched by Johnson & Johnson subsidiary Acclarent for use in ...Learn More
FDA panel backs new indication for Dexcom's glucose monitor
An FDA panel has voted in favor of approving Dexcom's G5 Mobile Continuous Glucose Monitoring System for use as a ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
Oct. ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
The greatest mistake you can make in life is to continually be afraid you will make one.
Elbert Hubbard, writer and ...Learn More
Funding round pulls in $52M for RefleXion Medical
A round of Series B financing led by KCK Group has brought in $52 million for RefleXion Medical. ...Learn More
Adherium obtains $5.9M in private placement
A private placement of 16 million shares involving Fidelity International has pulled in $5.9 million for Melbourne, ...Learn More
4 life sciences companies receive $200K each through Md. fund
The Maryland Technology Development Corp.'s Life Science Investment Fund has awarded four companies grants worth $200,000 ...Learn More
Zimmer Biomet training facility to be opened in India
A multiyear collaboration has been reached by Zimmer Biomet and Indo UK Institutes of Health to expand India's health care ...Learn More
Report predicts growth for US medical device outsourcing market
A Grand View Research report predicts the US medical device outsourcing market will hit $27.8 billion by 2022. ...Learn More
Study shows positive results for Medrobotic's robotic system
An 80-patient, open-label study presented at the American Head & Neck Society International Conference showed positive ...Learn More
Drugmakers race to create smart inhalers for medication adherence
Manufacturers of inhalers and generic drugs for asthma and chronic lung disease -- some of whom are collaborating with ...Learn More
FDA clears spinal pedicle screw set from Medtronic
The FDA has given Medtronic 510(k) clearance for its CD Horizon fenestrated spinal pedicle screw set, which is indicated for ...Learn More
EU OKs HTG's cell-of-origin assay, NGS platform
European regulators have given HTG Molecular Diagnostics CE IVD mark approval to market its HTG EdgeSeq system and HTG ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
Sept. 27-28 | Washington, D.C. ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
Sept. 28-29 | Washington, D.C. ...Learn More
Don't be afraid of missing opportunities. Behind every failure is an opportunity somebody wishes they had missed.
Jane Wagner, writer and ...Learn More
InnFocus to be acquired by Santen Pharmaceutical
Santen Pharmaceutical has agreed to pay $225 million upfront plus potential milestone payments to acquire InnFocus, ...Learn More
TPG Capital buys RoundTable Healthcare's ophthalmic surgical device unit
A deal has been reached by private investment firm TPG Capital to acquire RoundTable Healthcare Partners' ophthalmic ...Learn More
Bioventus to float 8.8M shares in IPO
Bioventus said it intends to offer 8.8 million shares in an initial public offering with the goal of raising $150 million. ...Learn More
J&J to consider deals of any size for its businesses, CFO says
Johnson & Johnson will take into consideration deals of any size in areas that could "add a whole other therapeutic focus" ...Learn More
Invictus Medical prioritizing sales under temporary CEO
San Antonio-based Invictus Medical is looking to establish a stable sales infrastructure before hiring a permanent ...Learn More
New president, CEO named by Monteris Medical
Martin Emerson, former CEO of Galil Medical, has been tapped to serve as president and CEO of Plymouth, Minn.-based Monteris ...Learn More
Study shows positive results for Harpoon Medical's heart valve repair device
A study in the journal Circulation showed positive results for the Harpoon TSD-5, an image-guided needle developed by ...Learn More
Patient enrollment for IlluminOss Medical's fixation system completed
The enrollment of 80 patients at 13 sites in the first US clinical trial of the IlluminOss System has been completed by ...Learn More
Cefaly unveils new version of migraine therapy device
The Cefaly II, a smaller version of the Cefaly migraine therapy device approved by the FDA for preventing migraines, has ...Learn More
EU OKs Medtronic's mobile continuous glucose monitoring system
European regulators have given Medtronic CE mark approval for its Guardian Connect mobile continuous glucose monitoring ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Your most unhappy customers are your greatest source of learning.
Bill Gates, entrepreneur and ...Learn More
Zimmer Biomet to acquire Medtech for at least $132M
Zimmer Biomet has reached an agreement to acquire French robot-assisted surgery company Medtech for at least $132 million. ...Learn More
Funding round pulls in $20.3M for Cambridge Medical Robotics
A round of Series A financing led by ABB Technology Ventures has brought in $20.3 million for Cambridge Medical Robotics, a ...Learn More
Private placement extended by Titan Medical
A private placement with China-based Shanghai Jugu Equity Investment Fund, which could raise about $16 million, has been ...Learn More
Bayer teams up with T2 Biosystems on hemostasis R&D
A multiyear collaboration deal has been reached by T2 Biosystems and Bayer to create tools and assess tests using the T2 ...Learn More
Report predicts growth for global optical imaging system market
A Grand View Research report predicts the worldwide optical imaging system market will hit $3 billion by 2024. ...Learn More
Q2 sales rise for BioMerieux
BioMerieux generated $568.6 million in sales during the three months ending June 30, up about 6% from the same period a year ...Learn More
FDA releases new guidance on 3D printing
The FDA recently released new guidance documents on 3D printing. ...Learn More
New site added by InVivo Therapeutics for neurospinal scaffold trial
Ben Taub Hospital at the Texas Medical Center in Houston has been added by InVivo Therapeutics as a new location for the ...Learn More
FDA registration obtained by Varian for collimators
The Claymount Optica 20 and Optica 40 collimators developed by Varian Medical Systems have been registered with the FDA. ...Learn More
FDA approves Medtronic's cervical disc for 2-level applications
Medtronic has obtained approval from the FDA for its Prestige LP Cervical Disc for use in treating cervical disc disease at ...Learn More
EU OKs vascular closure device from Essential Medical
European regulators have given Essential Medical CE mark approval for its Manta, a large bore vascular closure device that ...Learn More
Top 10 Product Liability Issues Webinar
July 20 | Virtual 1:00 p.m.-2:00 p.m. EasternLitigation funding. Off-label promotion. Parallel government investigations. ...Learn More
Wearable Devices Webinar: Regulatory and Litigation Risks
Sept. 15 | Virtual 1:00 p.m.-2:00 p.m. ...Learn More
The art of leadership is saying no, not yes. It is very easy to say yes.
Tony Blair, prime ...Learn More
Endonovo Therapeutics gets $10M boost
A funding agreement with an unnamed institutional investor has brought in $10 million for Endonovo Therapeutics. ...Learn More
Accel Biotech acquired by Ximedica
Accel Biotech has been acquired by Ximedica for undisclosed terms. ...Learn More
Siemens Healthineers' enterprise services now available in US
Siemens Healthineers has unveiled its Enterprise Services business line in the US. ...Learn More
New R&D, training center opened by Boston Scientific in India
A 100,000-square-foot Institute for Advancing Science facility has been opened by Boston Scientific in India. ...Learn More
Survey: Zimmer Biomet, DePuy implants preferred by orthopedic surgeons
An iData Research survey found that orthopedic surgeons preferred to use implants from Zimmer Biomet and DePuy Synthes for ...Learn More
Medtronic expands oblique lateral interbody fusion platform with new components
Medtronic launched the Pivox Oblique Lateral Spinal System with Lateral Plate, designed specifically for OLIF25 procedures, ...Learn More
Abbott's heart stent wins approval from Canada
Abbott has obtained approval from Health Canada for its Absorb bioresorbable heart stent, a device that dissolves in three ...Learn More
Intraocular lenses from Abbott OK'd by FDA
The FDA has granted Abbott approval for its Tecnis Symfony Intraocular Lenses, which are designed to provide a full range of ...Learn More
FDA clears remote breathalyzer from Soberlink
The FDA has granted Soberlink 510(k) clearance for its Soberlink Breathalyzer for medical use by health care providers. ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
Innovation in Leadership: Maximizing Diversity in Your Organization
Aug. ...Learn More
We must always take sides. Neutrality helps the oppressor, never the victim. Silence encourages the tormentor, never the tormented.
Elie Wiesel, writer and ...Learn More
Deal to acquire Sequent Medical completed by Terumo unit
The $280 million purchase of Sequent Medical, maker of the Web aneurysm embolization device, has been finalized by Terumo ...Learn More
Funding round pulls in $32M for Endotronix
A round of Series C financing has brought in $32 million for Endotronix, bringing the company's funding to $50 million. ...Learn More
Titan Spine obtains "substantial" funding from Texas private equity firm
A round of funding involving Texas-based Southlake Equity Group has pulled in an undisclosed amount for Titan Spine, maker ...Learn More
Philips, Life-Assist team up to offer lifesaving devices in Western US
A partnership has been reached by Life-Assist and Philips Healthcare to expand access of Western U.S. ...Learn More
Report predicts growth for spinal stenosis market
A Future Market Insights report predicts the spinal stenosis market will see growth through 2020 as a result of increasing ...Learn More
Study shows positive results for Edwards Lifesciences' heart valve
A study in the journal Circulation showed positive results for Edwards Lifesciences' Sapien 3 valve. ...Learn More
Extremity fixation anchor debuted by Stryker
Stryker on Thursday announced the launch of its SonicAnchor, a device that liquefies using sonic energy and flows into ...Learn More
CMS, FDA call for UDI use in insurance billing
Unique device identifiers should be included on universal health insurance claims forms to improve value-based reimbursement ...Learn More
FDA OKs Spirox's Latera nasal implant
The FDA has granted Menlo Park, Calif-based Spirox 510(k) clearance for its Latera absorbable nasal implant. ...Learn More
Longer drug-coated balloon from Medtronic gets FDA nod
Medtronic has obtained approval from the FDA for the new versions of its IN.PACT Admiral drug-coated balloon, indicated for ...Learn More
Top 10 Product Liability Issues Webinar
July 20 | Virtual 1:00 p.m.-2:00 p.m. EasternLitigation funding. Off-label promotion. Parallel government investigations. ...Learn More
10th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference
April 25-26, 2017 | Washington, D.C. ...Learn More
There is nothing more difficult to take in hand, more perilous to conduct, or more uncertain in its success, than to take the lead in the introduction of a new order of things.
Niccolo Machiavelli, historian and ...Learn More
Deal to acquire LDR Holding finalized by Zimmer Biomet
The acquisition of LDR Holding, valued at $1 billion, was completed by Zimmer Biomet on Wednesday, making LDR its indirect ...Learn More
Magnolia Medical obtains $13.8M in funding round
A round of Series B financing led by HealthQuest Capital has brought in $13.8 million for Seattle-based Magnolia Medical ...Learn More
Funding round brings in $6M for Augmenix
A round of Series E financing has pulled in $6 million for Augmenix, which makes the SpaceOAR system for protecting the ...Learn More
Integrated Healing Technologies gets $2M boost
A round of equity funding involving 42 anonymous investors has brought in $2 million for Integrated Healing Technologies, a ...Learn More
Report: Global spinal trauma devices market poised for growth
A Transparency Market Research report predicts the worldwide spinal trauma devices market will hit $4.7 billion by 2023 with ...Learn More
New board member named by Boston Scientific
Yoshiaki Fujimori has been tapped to serve on the board of directors at Boston Scientific. ...Learn More
FDA grants IDE approval for Cohera Medical's surgical sealant
The FDA has granted Cohera Medical an investigational device exemption to conduct a trial of its Sylys Surgical Sealant, a ...Learn More
New version of NovoCure's glioblastoma therapy device wins FDA nod
NovoCure has obtained approval from the FDA for its second-generation Optune system, a battery-powered tumor-treating field ...Learn More
FTC seeks more details about Abbott's $25B deal with St. Jude Medical
The Federal Trade Commission has sent a request for additional information about Abbott Laboratories' proposed $25 billion ...Learn More
SinuSys' sinus dilation devices cleared by FDA
The FDA has given Palo Alto, Calif.-based SinuSys 510(k) clearance for two of its Vent-Os sinus dilation devices. ...Learn More
Medical Device Complaints, MDRs & Reports Workshop
Oct. ...Learn More
Cybersecurity Summit
Nov. ...Learn More
There is a certain relief in change, even though it be from bad to worse; as I have found in traveling in a stagecoach, that it is often a comfort to shift one's position, and be bruised in a new place.
Washington Irving, ...Learn More
TransMedics gets $12.5M boost
A round of funding involving 20 investors has brought in $12.5 million for Andover, Mass.-based TransMedics, bringing the ...Learn More
DARPA, Army award Profusa $7.5M grant for biosensor development
The Defense Advanced Research Projects Agency and the US Army Research Office have awarded Profusa a grant worth $7.5 ...Learn More
Funding round brings in $10M for ImmunArray
A round of Series B financing led by private investment company Exigent Capital has pulled in $10 million for Israel-based ...Learn More
Brown to step down as CFO of Smith & Nephew
Julie Brown will step down as chief financial officer of Smith & Nephew in January 2017 after working for the company for ...Learn More
President and CEO named by Cogentix Medical
Darin Hammers has been named president and CEO of Cogentix Medical after serving in that role on an interim basis. ...Learn More
InVivo wins FDA nod to expand neuro-spinal scaffold study
The FDA has given InVivo Therapeutics approval to expand a trial of its Neuro-Spinal Scaffold, which serves as a physical ...Learn More
Guidance system for spine surgeries debuted by Mazor Robotics
The Mazor X, a platform that provides preoperative analytics, real-time 3D verification and intraoperative guidance for ...Learn More
House bill would improve local coverage determination process
A bill that would improve the local coverage determination process through the addition of several requirements, including a ...Learn More
For more:
Read AdvaMed's statement about House legislation that would improve the Medicare LCD ...Learn More
Final guidance on proving medtech electromagnetic compatibility released by FDA
A final guidance has been released by the FDA outlining the information medical device makers need to submit to support the ...Learn More
PMA supplement for Medtronic's artificial disc OK'd by FDA
The premarket approval supplement filed by Medtronic for its Prestige LP artificial disc, originally approved for treating ...Learn More
Innovation in Leadership: Maximizing Diversity in Your Organization
Aug. ...Learn More
Wearable Devices Webinar: Regulatory and Litigation Risks
Sept. 15 | Virtual 1:00 p.m.-2:00 p.m. ...Learn More
A failure is a man who has blundered but is not able to cash in on the experience.
Elbert Hubbard, writer and ...Learn More
Corin Orthopaedics offers $32.9M to buy Wright Medical's large-joints business
Corin Orthopaedics has submitted a binding offer to buy Wright Medical's legacy Tornier large-joints business in a nearly ...Learn More
Endonovo to buy Rio Grande Neurosciences for $21.5M
A letter of intent has been signed by Endonovo Therapeutics to buy Rio Grande Neurosciences, a developer of devices for ...Learn More
Avita Medical gets $9M boost
A rights issue of almost 100.2 million shares has brought in $9 million for Avita Medical, maker of the ReCell regenerative ...Learn More
Funding round pulls in $1.9M for AcuFocus
A round of debt financing involving 14 unnamed investors has brought in almost $1.9 million for Irvine, Calif.-based ...Learn More
Report predicts growth for global trauma fixation market
A GlobalData report predicts the worldwide trauma fixation market will reach $7.4 billion by 2020 with a 2.2% compound ...Learn More
Olympus unit to begin service center construction in Tenn.
Ground will be broken Thursday for Olympus Surgical Technologies America's $12 million East Coast National Service Center in ...Learn More
First procedure using absorbable heart stent recorded by Abbott
A patient at HonorHealth Scottsdale Shea Medical Center in Arizona was the first in the US to undergo a procedure using ...Learn More
FDA OKs St. Jude Medical's cardiac resynchronization therapy software
St. ...Learn More
Top FDA officials: US needs better tracking system for medical devices
The US should integrate the National Evaluation System for Health Technology with EHRs, device registries developed by ...Learn More
InSightec's ablation device for essential tremor wins FDA nod
The FDA has granted InSightec approval for its Exablate Neuro, a focused ultrasound device intended for treating essential ...Learn More
Top 10 Product Liability Issues Webinar
July 20 | Virtual 1:00 p.m.-2:00 p.m. EasternLitigation funding. Off-label promotion. Parallel government investigations. ...Learn More
Quality Audit Readiness Webinar
Aug. 23 | Virtual 1:00 p.m.-2:00 p.m. EasternAre you ready to showcase your quality systems and face an FDA inspection? ...Learn More
There are two ways of spreading light: to be the candle or the mirror that reflects it.
Edith Wharton, ...Learn More
Offering brings in $14.6M for InspireMD
An offering of 442,424 shares of Series B stock and warrants has brought in $14.6 million for Boston-based InspireMD. ...Learn More
Securities offering could pull in $14M for 3Scan
An offering of securities that could raise $14 million has been filed by tissue analytics startup 3Scan. ...Learn More
Amedica obtains $12.7M in offering
Amedica, a maker of silicone nitride spinal implants, has raised $12.7 million in an underwritten public offering of common ...Learn More
Report predicts growth for orthopedic devices market
A Grand View Research report predicts the orthopedic devices market will hit $43.1 billion by 2024 due to an increase in ...Learn More
Trice Medical names new chief commercialization officer
Mark Foster, former vice president of US sports medicine for Smith & Nephew, has been selected to serve as chief ...Learn More
New chief operating officer named by Precision Spine
Christopher DeNicola, who has over 25 years of medical device industry experience, has been tapped to serve as chief ...Learn More
Essential's vascular access closure device study gets FDA OK
The FDA has given Essential Medical approval to perform a clinical trial assessing the efficacy and safety of vascular ...Learn More
EU expands approval for Nexstim's brain therapy system
European regulators have given Nexstim expanded CE mark approval for its Navigated Brain Therapy system for use in treating ...Learn More
FDA OKs use of Roche's HPV test with BD's preservative fluid
Roche Molecular Diagnostics has secured approval from the FDA for its Roche cobas HPV Test for use with Becton Dickinson's ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
All journeys have secret destinations of which the traveler is unaware.
Martin Buber, ...Learn More
Senseonics gets $30M boost
Glucose monitor maker Senseonics has secured $30 million under a term loan agreement with Oxford Finance and Silicon Valley ...Learn More
Bio-Techne to purchase Advanced Cell Diagnostics in $325M deal
Advanced Cell Diagnostics will be acquired by Bio-Techne in a deal that will broaden the latter's product portfolio into ...Learn More
Laborie Medical buys stake in Medi-Tate
Toronto-based Laborie Medical Technologies has invested an unspecified amount in Israel-based Medi-Tate. ...Learn More
HTG, Firalis enter rheumatoid arthritis theranostic partnership
France-based Firalis and HTG Molecular Diagnostics will partner to develop RABIOPRED, a next-generation sequencing-based ...Learn More
Report: First-half M&A value grows for medtech industry
The medical devices industry experienced a 45.5% growth in the value of mergers and acquisitions in the first half of the ...Learn More
Permanent CEO named by Safe Orthopaedics
Pierre Dumouchel, who was interim CEO of Safe Orthopaedics, has been appointed its permanent CEO. ...Learn More
Camber records first US procedure using interbody fusion device
A patient at Kennedy University Hospital-Washington Township in Turnersville, N.J., was the first in the US to undergo a ...Learn More
FDA clears Prism's safety capsule platform
The FDA has given Coral Springs, Fla.-based Prism Medical & Design clearance for its ProteXsure Safety Capsule System, an ...Learn More
FDA, EU clear in vitro diagnostic system from Luminex
The FDA has given Luminex clearance for its ARIES M1 system, an in vitro diagnostic platform that can process six assays and ...Learn More
Cardiovascular Systems seeks Japan's approval for heart device
St. ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
Sept. 27-28 | Washington, D.C. ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
Sept. 28-29 | Washington, D.C. ...Learn More
When I dare to be powerful, to use my strength in the service of my vision, then it becomes less and less important whether I am afraid.
Audre Lorde, writer and ...Learn More
DFINE acquired by Merit Medical in $97.5M deal
Merit Medical Systems on Wednesday said it acquired San Jose, Calif.-based DFINE for $97.5 million in cash, making DFINE its ...Learn More
Funding round pulls in $4.1M for Ortho Kinematics
A round of funding involving 55 investors has brought in about $4.1 million for Austin, Texas-based Ortho Kinematics, ...Learn More
Ind. medical device accelerator secures $1.6M in funding
AcceLinx, an accelerator launched by Indiana's orthopedics initiative OrthoWorx to provide medical device entrepreneurs with ...Learn More
Deal to acquire Symmetry Surgical finalized by RoundTable Healthcare
The acquisition of Symmetry Surgical, a Nashville, Tenn.-based single-use surgical instruments and specialty devices ...Learn More
Genomic Health, Epic Sciences reach commercialization deal
Genomic Health has agreed to commercialize an AR-V7 liquid biopsy test from Epic Sciences in the US and make an equity ...Learn More
New chief commercial officer named by SI-BONE
Tony Recupero, former CEO of Baxano, has been selected to serve as chief commercial officer of SI-BONE. ...Learn More
Study shows positive results for St. Jude Medical's heart failure device
A study presented at the American Association of Heart Failure Nurses' annual meeting showed positive results for St. ...Learn More
EU OKs bioMerieux's updated clinical microbiology system
European regulators have given bioMerieux CE mark approval to market a database and reagent kits as additions to its VITEK ...Learn More
Synthetic cartilage implant from Cartiva wins FDA nod
The FDA has given Cartiva approval for its Cartiva Synthetic Cartilage Implant, a molded cylindrical device indicated for ...Learn More
FDA clears ultrasonic surgical device from Ethicon
Johnson & Johnson subsidiary Ethicon has secured 510(k) clearance from the FDA for its Harmonic HD 1000i, an ultrasonic ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
A sheltered life can be a daring life as well. For all serious daring starts from within.
Eudora Welty, ...Learn More
Deal to acquire Biotronic NeuroNetwork finalized by NuVasive
NuVasive said on Tuesday that its $98 million all-cash acquisition of Ann Arbor, Mich.-based Biotronic NeuroNetwork has been ...Learn More
Funding round brings in $13.9M for NightBalance
A second round of financing led by INKEF Capital and Gilde Healthcare Partners has brought in $13.9 million for ...Learn More
Offering could pull in $11M for Amedica
A public equity offering of common stock and warrants has been priced by Amedica in hopes of obtaining about $11 million in ...Learn More
Viveve widens distribution in Latin America with 6 deals
Six distribution agreements have been reached by Viveve to bring its Viveve System, a nonsurgical device designed for ...Learn More
Health Care Service Corp. to cover EndoGastric's fundoplication procedure
EndoGastric Solutions has secured a positive coverage policy from Health Care Service Corp. ...Learn More
Study shows positive results for brachytherapy with C4 Imaging's MRI marker
A study presented at the World Congress of Brachytherapy in San Francisco showed positive results for MRI-guided prostate ...Learn More
DeepMind takes a crack at predicting eye disease
Google DeepMind's supercomputer proved itself at the highest levels of the complex game Go and is now facing another ...Learn More
Abbott Laboratories' absorbable heart stent wins FDA nod
Abbott Laboratories has obtained approval from the FDA for its Absorb heart stent, a polymer device that dissolves within ...Learn More
Expanded use of TSO3's sterilization device cleared by FDA
The Sterizone VP4 sterilizer device from Canada-based TSO3 has been cleared by the FDA for an expanded indication. ...Learn More
Canada OKs surgical navigation system from Synaptive Medical
Health Canada has given Synaptive Medical approval to market its surgical navigation system called BrightMatter Guide. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
The quality of strength lined with tenderness is an unbeatable combination, as are intelligence and necessity when unblunted by formal education.
Maya Angelou, writer and civil rights ...Learn More
Spirometrix gets $17.4M boost
The first tranche of a Series C financing round has brought in $17.4 million for Pleasanton, Calif.-based Spirometrix. ...Learn More
Offering could pull in $15M for InspireMD
A public offering of 442,424 shares of Series B convertible preferred stock and warrants has been priced by InspireMD in ...Learn More
Prosidyan teams up with MO-SCI to develop orthopedic technology
A partnership has been reached by Rolla, Mo.-based MO-SCI and Warren, N.J.-based Prosidyan to develop orthopedic technology ...Learn More
NuVasive to expand workforce for new Ohio plant
NuVasive says it will begin hiring more employees this month for its new $45 million manufacturing facility in West ...Learn More
New president, CEO named by Amendia
Chris Fair has been promoted to president and CEO at Amendia, where he previously served as chief operating officer. ...Learn More
First commercial use of low-profile delivery system recorded by Lombard
A patient at the Complexo Hospitalario Universitario de Ourense in Spain was the first to undergo a procedure using Lombard ...Learn More
Researchers working on device for 3D imaging-based breast cancer detection
Dilon Technologies, Jefferson Lab and the University of Florida are developing and testing a variable angle slant hole ...Learn More
Medtech industry input sought for improving FDA's facility inspection plan
The FDA is encouraging the medical device industry to submit input on training and communication issues about its "program ...Learn More
EU OKs pacemakers from Biotronik
European regulators have granted Biotronik CE mark approval to market its Edora pacemakers and cardiac resynchronization ...Learn More
FDA clears wider use of bioMerieux's sepsis assay
The FDA has given bioMerieux 510(k) clearance for an additional indication of its Vidas BRAHMS PCT assay, which is intended ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
Never tell people HOW to do things. Tell them WHAT to do, and they will surprise you with their ingenuity.
George S. Patton, military ...Learn More
IPO could pull in $150M for Bioventus
An initial public offering that could raise $150 million has been filed by Durham, N.C.-based Bioventus. ...Learn More
Great Basin gets $75M boost
A securities purchase deal has been reached by Great Basin Scientific with institutional investors, bringing in $75 million. ...Learn More
Deal to acquire Nanosphere finalized by Luminex
Luminex on Thursday said its acquisition of Nanosphere, valued at about $76.9 million, has been completed "without a vote of ...Learn More
Report: Global orthopedic devices market poised for growth
A Grand View Research report predicts the worldwide market for orthopedic devices will hit $43.1 billion by 2024 amid an ...Learn More
Data show positive results for combination of Cook Medical's graft, stent
Data presented at the Society for Vascular Surgery's annual meeting showed positive initial results for a system combining ...Learn More
Sparo Labs' app-connected spirometer gets FDA OK for nonprescription use
St. ...Learn More
JustRight's surgical vessel sealing system cleared by FDA
The FDA has given Colorado-based JustRight Surgical 510(k) clearance for its 3-mm JustRight Surgical Vessel Sealing System. ...Learn More
AdvaMed applauds Biden's cancer initiative
The National Cancer Moonshot Summit, led by Vice President Joe Biden, has called on various stakeholders from public and ...Learn More
For more:
Read the statement from AdvaMed President and CEO Scott Whitaker and AdvaMedDx Executive Director Andy Fish supporting the ...Learn More
CMS report: Industry paid providers $6.49B last year
Medical device, biotech and drug companies paid $6.49 billion to 618,000 physicians and 1,110 teaching hospitals in 2015, ...Learn More
EU OKs temporary prostatic stent from SRS Medical
European regulators have granted SRS Medical Systems CE mark approval for its Spanner temporary prostatic stent, a device ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
Sept. 27-28 | Washington, D.C. ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
Sept. 28-29 | Washington, D.C. ...Learn More
SmartBrief will not publish Monday
In observance of Independence Day in the US, SmartBrief will not publish Monday. Publication will resume ...Learn More
A leader is best when people barely know that he exists. ... When his work is done, his aims fulfilled, they will all say, 'We did this ourselves.'
Lao Tzu, ...Learn More
DOD taps Zoll Medical for $400M vital signs monitor contract
The Department of Defense has awarded Zoll Medical a contract valued at $400 million to provide the Army and Air Force with ...Learn More
CogENT's Xerogel acquired by Entellus Medical for $11M
CogENT Therapeutics' XeroGel nasal/epistaxis pack, which is indicated for use in nasal and sinus surgeries, has been ...Learn More
NCI awards BioMarker Strategies $2.3M for companion Dx development
Rockville, Md.-based BioMarker Strategies said it will develop a companion diagnostic for non-small cell lung cancer ...Learn More
Report: Global ophthalmology devices market poised for growth
A Transparency Market Research report predicts the worldwide market for ophthalmology devices will reach $18.28 billion by ...Learn More
Report predicts uptick in global knee, hip reconstruction market
The worldwide hip and knee reconstruction market will hit $16.46 billion by 2022 with a 2.5% compound annual growth rate, ...Learn More
IMS Health joins study of Avita Medical's regenerative medical device
Health economics group IMS Health has been tapped by Avita Medical to participate in a study of the latter's ReCell ...Learn More
Anterior cervical plate debuted by Amendia
The Ceres Midline Cervical Plate System has been launched by Amendia for providing anterior screw fixation as an adjunct to ...Learn More
Canada OKs automated peritoneal dialysis system from Baxter
Baxter International has obtained approval from Health Canada to market the AMIA automated peritoneal dialysis system, which ...Learn More
EU approves extracellular matrix envelope from CorMatrix
European regulators have given Roswell, Ga.-based CorMatrix Cardiovascular CE mark approval for its CorMatrix CanGaroo ...Learn More
Revision's implantable corneal device gets FDA nod
The FDA has granted Revision Optics approval for its Raindrop Near Vision Inlay, an implantable corneal device designed for ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Instruction does much, but encouragement everything.
Johann Wolfgang von Goethe, writer and ...Learn More
Funding round pulls in $7M for Owlstone Medical
A round of funding has brought in $7 million for Owlstone Medical, a Cambridge, UK-based disease breathalyzer developer. ...Learn More
PureTech startup launched to develop audio biomarker analysis technology
Sonde Health has been launched by Boston-based PureTech Health to develop a health monitoring audio analysis technology to ...Learn More
Illumina agrees to team up with MolecularMD on companion Dx
A deal has been reached by Illumina and MolecularMD to collaborate on developing next-generation sequencing-based companion ...Learn More
Entellus Medical, Fiagon reach distribution deal
Entellus Medical has reached an agreement with Fiagon to exclusively distribute the latter's Image Guidance Systems to ...Learn More
Abiomed exec joins Bioventus' board of managers
Michael Minogue, CEO, president and chairman of Abiomed, has been tapped to serve on Bioventus' board of managers. ...Learn More
Study shows positive results for W.L. Gore's endoprosthesis device
A study in the Journal of Vascular Surgery showed positive results for W.L. ...Learn More
Heart failure monitoring service debuted by Medtronic in US
The Beacon heart failure management service has been introduced by Medtronic in the US for improving early interventions ...Learn More
Devices first OK'd by EU linked to greater safety issues, study finds
Medical devices that received approval first from the European Union are three times more likely to be under recalls and ...Learn More
FDA releases order to classify power morcellation containment systems
Gynecologic laparoscopic power morcellation containment systems have been classified as Class II special control devices ...Learn More
Wireless patient monitor from Masimo cleared by FDA
The FDA has granted Masimo 510(k) clearance for its Radius-7 wireless patient monitor, a wearable device that features the ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
An attitude of positive expectation is the mark of the superior personality.
Brian Tracy, motivational ...Learn More
Medtronic reaches $1.1B deal to acquire HeartWare
Medtronic on Monday announced it will pay about $1.1 billion in cash to acquire HeartWare International. ...Learn More
Funding round pulls in $51M for Earlens
A round of funding involving Medtronic, Cochlear and other investors has pulled in $51 million for Menlo Park, Calif.-based ...Learn More
BARDA extends contract with Avita Medical for $7.96M
The Biomedical Advanced Research and Development Authority has extended its contract with Avita Medical with $7.96 million ...Learn More
Emerge Diagnostics obtains $1.85M in funding round
A round of financing has pulled in $1.85 million for Carlsbad, Calif.-based Emerge Diagnostics, maker of the ...Learn More
US antitrust waiting period cleared by Zimmer Biomet for LDR purchase
Zimmer Biomet said Monday the required waiting period under US antitrust regulations has ended for its acquisition of LDR ...Learn More
Data show promising results for Cook Medical's endovascular device
Data from a 73-patient study presented at the Society for Vascular Surgery's annual meeting showed positive results for Cook ...Learn More
EU OKs BioVentrix's transcatheter ventricular enhancement system
European regulators have given San Ramon, Calif.-based BioVentrix CE mark approval for its Revivent TC transcatheter ...Learn More
Medtronic seeks FDA approval for artificial pancreas
Medtronic has submitted an application seeking FDA approval for the MiniMed 670G, an artificial pancreas that features a ...Learn More
Image-guided radiotherapy system from Accuray gets FDA nod
The FDA has given Accuray 510(k) clearance for its Radixact Treatment Delivery System, which comes as an upgrade to the ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
Managers are people who do things right, and leaders are people who do the right thing.
Warren Bennis, business ...Learn More
Funding round pulls in $3.4M for Arkis BioSciences
A round of Series A financing led by Innova Memphis has brought in $3.4 million for Knoxville, Tenn.-based Arkis ...Learn More
Medtronic teams up with global medical group to raise stroke awareness
A partnership has been reached by Medtronic and the World Stroke Organization to develop global stroke awareness initiatives ...Learn More
Pa. insurer to cover Boston Scientific device-based bronchial thermoplasty
Pennsylvania-based health insurer Independence Blue Cross has started providing coverage for bronchial thermoplasty ...Learn More
Nasdaq allows Great Basin to fulfill continued listing requirements
The Nasdaq listing qualifications panel has given Great Basin Scientific additional time to regain its compliance with the ...Learn More
Report predicts growth for European spine surgery devices market
A Market Reports World report predicts the European market for spine surgery devices will reach $2.37 billion by 2020 with a ...Learn More
Anesthesia monitoring devices market poised for growth, report finds
A Grand View Research report predicts the anesthesia monitoring devices market will grow to $1.9 billion by 2024 amid an ...Learn More
Study shows positive results for Helius' portable neuromodulation stimulator
A pilot study presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers showed positive results ...Learn More
Hybrid fractional laser for vaginal tissue unveiled by Sciton
A hybrid fractional laser called diVa has been launched by Palo Alto, Calif.-based Sciton for use in vaginal tissue ...Learn More
FDA clears subtalar arthroereisis implant from Life Spine unit
The FDA has given Centric Medical, Life Spine's foot and ankle division, 510(k) clearance for its Subtalar Arthroereisis ...Learn More
Avitus' bone-graft collection device receives FDA nod
Avitus Orthopaedics has received FDA approval to market its Bone Harvester, designed for collecting bone marrow and bone ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
The most difficult thing is the decision to act. The rest is merely tenacity.
Amelia Earhart, ...Learn More
AdvaMed applauds House Health Care Task Force report
The House Health Care Task Force has released a report outlining a Republican-recommended plan for the US health care ...Learn More
For more:
Read the statement from AdvaMed President and CEO Scott Whitaker about the House Health Care Task Force ...Learn More
Offer for Exiqon's shares completed by Qiagen
Qiagen on Thursday announced the completion of its tender offer for Exiqon's shares after it received acceptances from ...Learn More
Funding round pulls in $18M for Reflexion Health
A round of Series B financing has brought in $18 million for Reflexion Health, a digital health company that specializes in ...Learn More
Priority Health to cover MDxHealth's prostate cancer test
Priority Health, a Michigan-based health plan company, has agreed to cover MDxHealth's ConfirmMDx test for prostate cancer, ...Learn More
Masimo enters partnership with SunTech Medical
A partnership has been reached by SunTech Medical and Masimo to combine the latter's SET pulse oximetry technology with ...Learn More
Report predicts growth for global medical automation market
A Grand View Research report predicts the worldwide market for medical automation will reach $79.4 billion by 2024 amid ...Learn More
Data show promising results for GI Dynamics' weight-loss device
Data from a 325-patient study presented at the American Diabetes Association's recent meeting showed overall positive ...Learn More
New cardiac imaging platform unveiled by HeartFlow
HeartFlow on Thursday announced the launch of its HeartFlow FFRCt Analysis, which is the newest version of the company's ...Learn More
EU OKs cardiac resynchronization therapy solutions from St. Jude Medical
European regulators have given St. ...Learn More
Australia OKs integrated interbody system from Centinel Spine
Centinel Spine has secured clearance from the Australian Therapeutic Goods Administration for its STALIF L No-Profile ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
The greater the artist, the greater the doubt. Perfect confidence is granted to the less talented as a consolation prize.
Robert Hughes, art ...Learn More
ETView sold to Danish company for $16M
Denmark-based medical device firm Ambu has reached an agreement valued at $16 million to acquire ETView Medical, an ...Learn More
Global collaborative effort on medical imaging unveiled by IBM
IBM Watson Health is launching the Watson Health Medical Imaging Collaborative, a 16-member global initiative composed of ...Learn More
MEDIAN Technologies, Microsoft to collaborate on real-time cancer solutions
A collaborative deal with undisclosed terms has been reached between MEDIAN Technologies and Microsoft to use big-data ...Learn More
Report predicts growth for North American spine surgery devices market
A Medical Market Research report predicts the North American market for spine surgery devices will see a 7.5% compound ...Learn More
VP of investor relations to retire from J&J
Louise Mehrotra will retire as vice president of investor relations at Johnson & Johnson effective January 2017. ...Learn More
Data show positive results for Abbott's rotor ablation technology
Data from studies presented at Cardiostim-EHRA Europace 2016 showed positive results for Abbott's RhythmView technology. ...Learn More
Molecular diagnostic analyzer unveiled by Great Basin
The GB550 molecular diagnostic analyzer has been introduced by Great Basin Scientific at the American Society for ...Learn More
India scraps drugs amendment bill, will create separate rules for medtech
The Indian government on Wednesday dropped legislation it was preparing that would have amended the country's Drugs and ...Learn More
FDA names new director of premarket review office
John Sheets, the former chief scientific officer at Anika Therapeutics, has been tapped to serve as director of the FDA's ...Learn More
EU OKs infection disease test from Ortho Clinical
European regulators have given Ortho Clinical Diagnostics CE mark approval for its VITROS HIV combo test. ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
I was taught that the way of progress is neither swift nor easy.
Marie Curie, physicist and ...Learn More
NovellusDx funding round hits $12.5M
Israel-based cancer diagnostics firm NovellusDx has received $2.5 million in additional funding from health care investment ...Learn More
S.C. life sciences accelerator to be launched by MUSC, entrepreneur center
PriMed, a South Carolina-based accelerator program for early-stage medtech companies and other life sciences startups, will ...Learn More
Royal Philips, Visiopharm partner on breast cancer diagnostic imaging
A partnership deal has been reached by Royal Philips and Visiopharm to combine the latter's image analysis software with ...Learn More
Report: Global orthopedic trauma devices market poised for growth
A Persistence Market Research report predicts the worldwide market for orthopedic trauma devices will reach $9.4 billion by ...Learn More
Upper-extremities president of Wright Medical steps down
Terry Rich has resigned as upper-extremities president of Wright Medical. ...Learn More
Global urban microbiome consortium teams up with Qiagen, CosmosID
The Metagenomics and Metadesign of Subways and Urban Biomes consortium, led by Weill Cornell Medicine, is partnering with ...Learn More
Cardiac tissue repair device for neonates, infants introduced by CorMatrix
CorMatrix Cardiovascular has announced the phased commercial launch of its cardiac tissue repair patch called CorMatrix Tyke ...Learn More
Spinal Elements' expandable interbody fusion devices cleared by FDA
Carlsbad, Calif.-based Spinal Elements has obtained clearance from the FDA for its expandable interbody fusion devices for ...Learn More
EU OKs Polyganics' device for neuroma formation reduction
European regulators have given Polyganics CE mark approval for Neurocap, an absorbable, implantable device intended for ...Learn More
Zika virus assay from Hologic, Grifols approved by FDA
The Procleix assay, a test developed by Hologic and Grifols for screening US blood supply for the Zika virus, has received ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Character consists of what you do on the third and fourth tries.
James A. Michener, ...Learn More
Irish digital pathology tech firm acquired by Philips
Belfast, Ireland-based PathXL, a developer of digital pathology technology, has been acquired by Philips for undisclosed ...Learn More
Cerus, Terumo secure BARDA contracts for blood pathogen reduction
In an effort to reduce the risk of transmitting pathogens, such as Zika virus, by blood transfusion, HHS's Biomedical ...Learn More
Cardica becomes Dextera Surgical
Cardica has announced that it is changing its name to Dextera Surgical, effective Wednesday, to highlight the company's ...Learn More
Report predicts growth for global spine biologics market
A Technavio report predicts the worldwide market for spine biologics will reach $1.74 billion by 2020. ...Learn More
Brightree announces leadership changes
Matt Mellott, former president of MedBridge Healthcare, has been tapped to serve as CEO of Atlanta-based health care ...Learn More
First US procedures using opioid addiction implant recorded by Braeburn
Patients in Florida, Pennsylvania and California were the first in the US to be treated with Braeburn Pharmaceuticals' ...Learn More
Expandable interbody fusion system unveiled by Spineology
The Elite Expandable Interbody Fusion System has been unveiled by Spineology for use in minimizing neural retraction and ...Learn More
CMS moves implementation of market-based payment for lab tests to 2018
The CMS issued its final rule on the Protecting Access to Medicare Act of 2014 and put off until Jan. ...Learn More
For more:
Read the statement from AdvaMedDx on the CMS clinical diagnostic lab test payment system final ...Learn More
Final guidance on data extrapolation for pediatric devices released by FDA
The FDA has issued final guidance outlining the circumstances and methods through which manufacturers can extrapolate data ...Learn More
EU OKs stent graft delivery system from Lombard Medical
European regulators have given Lombard Medical Technologies CE mark approval for its IntelliFlex low-profile delivery ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Strength does not come from physical capacity. It comes from an indomitable will.
Mahatma Gandhi, social ...Learn More
Funding round pulls in $46M for CVRx
A round of funding has brought in $46 million for Minneapolis-based CVRx. ...Learn More
Mainstay Medical gets $34M boost
A placement of 2.3 million ordinary shares has pulled in about $34 million for Ireland-based medical device firm Mainstay ...Learn More
SI-BONE obtains $20M in funding round
San Jose, Calif.-based SI-BONE has secured $20 million in a round of equity funding involving nine unnamed investors, ...Learn More
IPO brings in $15.5M for Viveve
Sunnyvale, Calif.-based Viveve offered more than 3.1 million shares in an initial public offering with gross proceeds ...Learn More
Medtronic gets FDA IDE approval for laser ablation technology
The FDA has granted Medtronic an investigational device exemption to conduct a study evaluating the use of its Visualase ...Learn More
Airway clearance system debuted by Hill-Rom
The VisiVest System, a device intended to provide airway clearance therapy for patients with cystic fibrosis, has been ...Learn More
Benefit-risk guidance for device enforcement, compliance actions released by FDA
Draft guidance has been published by the FDA to outline the factors it considers when weighing a medical device's risks and ...Learn More
FDA unveils guidance on reporting, evaluation of subgroups in device studies
Draft guidance has been released by the FDA to offer recommendations on better reporting and evaluation of age-, race- and ...Learn More
MRI pacing lead from Biotronik gets FDA clearance
The FDA has given Biotronik clearance for its Solia S ProMRI pacing lead. ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
I don't want to get to the end of my life and find that I lived just the length of it. I want to have lived the width of it as well.
Diane Ackerman, ...Learn More
1315 Capital raises $200M for health care fund
Philadelphia-based 1315 Capital has secured $200 million for its first fund dedicated to commercial-stage medtech, ...Learn More
IPO could pull in $75M for OrthoPediatrics
An initial public offering that could raise as much as $75 million has been filed by Warsaw, Ind.-based OrthoPediatrics. ...Learn More
BD enters development, distribution deal with Check-Points
Becton Dickinson and Check-Points have reached an agreement to develop a real-time PCR kit for carbapenem-resistant organism ...Learn More
Kobold Medical taps Elekta in US distribution deal
Elekta has agreed to exclusively distribute Kobold Medical's Fletcher, Henschke, Tandem and Ring, and Vaginal Cylinder ...Learn More
Applied BioCode reaches partnership, supply deal with Diatherix
Applied BioCode and Diatherix Laboratories have agreed to develop multiplex molecular diagnostic panels for infectious ...Learn More
Study shows positive results for Respicardia's sleep apnea treatment device
A 151-patient, 31-site study presented at the annual meeting of the Associated Professional Sleep Societies showed positive ...Learn More
St. Jude Medical debuts deep-brain stimulation technology in EU
The Infinity Deep Brain Stimulation System and directional DBS lead have been launched in Europe by St. ...Learn More
FDA clears SpineGuard's pedicle screw insertion device
The FDA has given SpineGuard 510(k) clearance for its PediGuard threaded Dynamic Surgical Guidance device, which is ...Learn More
Laser therapy system from Boston Scientific gains NICE support
The UK's National Institute of Health and Care Excellence has issued positive guidance on Boston Scientific's GreenLight XPS ...Learn More
EU OKs BlueWind Medical's wireless neurostimulator
European regulators have given Israel-based device maker BlueWind Medical CE mark approval for its OAB-1000 system, a ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
Success seems to be connected with action. Successful people keep moving. They make mistakes, but they don't quit.
Conrad Hilton, ...Learn More
Funding round pulls in $172.5M for Nevro
An offering of convertible senior notes due in 2021 has brought in $172.5 million for Nevro. ...Learn More
Canary Health teams up with Medtronic on diabetes care
A partnership deal has been reached by Medtronic and digital health firm Canary Health to combine the latter's ...Learn More
New Dexcom plant to create 500 jobs in Ariz.
A 216,000-square-foot manufacturing facility that will create up to 500 jobs is being opened in Mesa, Ariz., by San ...Learn More
Covalon taps Medline for US distribution deal
Medline has agreed to distribute Covalon Technologies' products to its US customers, which include hospitals, surgery ...Learn More
Qiagen reaches global licensing deal with MDxHealth
Qiagen has secured a non-exclusive worldwide license to use MDxHealth's patented methylation-specific PCR technology in its ...Learn More
Report predicts growth for pain management devices market
A MarketsandMarkets report predicts the pain management devices market will reach $4.64 billion by 2021 with an 8.5% ...Learn More
Data show positive results for Silk Road Medical's transcarotid stent system
Data presented at the 2016 Vascular Annual Meeting of the Society for Vascular Surgery showed positive results for Silk Road ...Learn More
Interbody spacer unveiled by Amendia
The Ceres-C Stand-alone Cervical Interbody device, a low-profile polyetheretherketone interbody spacer with screws and a ...Learn More
EU OKs Biotronik's magnesium bioresorbable scaffold
European regulators have granted Biotronik CE mark approval for Magmaris, a magnesium-based bioresorbable scaffold indicated ...Learn More
FDA clears headed, snap-off screws from Tyber Medical
The FDA has granted Tyber Medical 510(k) clearance for its cannulated headed and snap-off screws, which are designed to be ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
You cannot change your destination overnight, but you can change your direction overnight.
Jim Rohn, ...Learn More
Royal Philips, J&J invest in $282M health care fund
Total funding of $282 million has been secured by Gilde Healthcare from investors including Royal Philips and Johnson & ...Learn More
Offering of Zimmer Biomet shares could pull in $1.29B
A secondary offering of about 11.1 million shares of common stock has been announced by Zimmer Biomet in hopes of raising ...Learn More
Vital Connect gets $25.3M boost
Vital Connect, a maker of wearable biometric diagnostic patches, has completed a term loan facility of $17.5 million from ...Learn More
IPO could bring in $13.5M for Viveve Medical
An initial public offering of 2.7 million shares of common stock has been priced by Viveve Medical in hopes of obtaining ...Learn More
NeuSpera Medical obtains $9M in funding round
A round of equity funding involving four anonymous investors has brought in $9 million for Santa Clara, Calif.-based ...Learn More
Medical 21 seeks alternative to harvesting blood vessels for bypass surgeries
Medtech firm Medical 21 is developing artificial blood vessels in an effort to prevent complications and scarring from ...Learn More
Data show positive results for Lombard Medical's stent graft
Data presented at the Society for Vascular Surgery's annual meeting showed positive results for Lombard Medical's Aorfix ...Learn More
Liquid biopsy test debuted by Genomic Health
The Oncotype SEQ Liquid Select, a next-generation sequencing-based assay that targets 17 genes to enhance treatment ...Learn More
Final FDA rule allows stand-alone symbols for device labeling
A final rule has been issued by the FDA to permit the use of symbols in labeling devices without accompanying explanatory ...Learn More
Aspire Bariatrics' obesity treatment device gets FDA approval
Pennsylvania-based Aspire Bariatrics has obtained approval from the FDA for its AspireAssist device, an external pump ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Intention without action is an insult to those who expect the best from you.
Andy Andrews, writer and motivational ...Learn More
Terumo reaches $375M deal to buy Calif. cranial catheter maker
Japan-based medical device firm Terumo will acquire California-based Sequent Medical, a maker of catheters for cerebral ...Learn More
Vivo Capital raises $100M-plus for health care fund
Over $100 million has been secured for the Vivo Panda fund, a new fund by Vivo Capital dedicated to early-stage medtech, ...Learn More
Surmodics to develop operations, add 100 jobs in Ireland
US life sciences technologies firm Surmodics plans to spend more than $7.85 million to develop a facility in Galway, ...Learn More
Titan Spine offers enhanced warranty for spinal fusion devices
Titan Spine is offering an upgraded warranty covering its Endoskeleton interbody fusion devices. ...Learn More
Intuitive Surgical, InTouch Health to collaborate on informatics solutions
InTouch Health, a Santa Barbara, Calif.-based telehealth provider, announced that it received a strategic investment from ...Learn More
Acelity brings wound care support to Fla. shooting victims
San Antonio-based wound care firm Acelity has provided the Orlando Regional Medical Center with its ABTHERA and INFOV.A.C. ...Learn More
Data show positive results for continuous glucose monitoring technology
Data from a review of literature presented by Dexcom at the American Diabetes Association Scientific Sessions showed that ...Learn More
Hemoglobin spot-checking technology from Masimo unveiled outside US
The Pronto Pulse CO-Oximeter with SpHb Spot Check technology has been launched by Masimo outside the US for use in ...Learn More
FDA clears updated indication for SI-BONE's implant
The FDA has given San Jose-Calif.-based SI-BONE clearance for a modified indication of the iFuse implant, which is currently ...Learn More
Regional oximetry from Masimo cleared by FDA
Irvine, Calif.-based Masimo has obtained 510(k) clearance from the FDA for its O3 regional oximetry, a device that uses ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
A reputation for one thousand years may depend upon the conduct of a single moment.
Ernest Bramah, ...Learn More
Compression Therapy Concepts acquired by Zimmer Biomet
The acquisition of Eatontown, N.J.-based Compression Therapy Products, a maker of non-invasive devices for deep-vein ...Learn More
Funding round brings in $10M for ReCor Medical
A round of debt financing involving an anonymous investor has brought in $10 million for ReCor Medical, according to a ...Learn More
Boston Scientific plans to build R&D center in India
Boston Scientific is looking to build a research and development facility in Gurgaon, India, from which it intends to launch ...Learn More
Medtronic, Ascensia renew co-development deal
An agreement between Medtronic and Ascensia Diabetes Care to create diabetes management solutions has been renewed for five ...Learn More
Report predicts growth for global spinal implants market
A Market Research report predicts the worldwide market for spinal implants will see a compound annual growth rate of 5.91% ...Learn More
Extravascular defibrillator under development at Medtronic
Medtronic is working on an implantable cardioverter defibrillator called the EV-ICD, which has leads meant to be placed ...Learn More
GSK looks to develop bioelectronic neural implants for chronic diseases
GlaxoSmithKline invested $50 million in bioelectronics, backed approximately 100 external researchers and launched a $6 ...Learn More
Australian firm's 3D-printed device for sleep disorders to be launched in US
The O2Vent, a 3D-printed titanium jaw advancement device designed for treating patients with obstructive sleep apnea and ...Learn More
China proposes new batch of devices for clinical trial exemption
A proposal to exclude 259 Class II devices and 93 Class III devices from being required to undergo local clinical trials has ...Learn More
FDA OKs robotic endoscopy system from Auris Surgical
The FDA has granted California-based Auris Surgical Robotics approval for its Auris Robotic Endoscopy System, indicated for ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Valor withers without adversity.
Seneca, ...Learn More
IPO could pull in $60M for Tactile Systems
An initial public offering that could raise $60 million has been filed by Minneapolis-based Tactile Systems Technology. ...Learn More
Royal Philips looks at billion-dollar-plus deals in health care informatics
Royal Philips is targeting companies in the health care informatics market for billion-dollar-plus acquisitions in the ...Learn More
NeuroMetrix obtains $21.3M in private placement
A private placement of stock and warrants has been completed by Waltham, Mass.-based NeuroMetrix with total proceeds of ...Learn More
Facility for life sciences startups to be launched by Harvard
The Harvard Life Lab, a $15 million-plus facility built by Harvard University, will be opened this fall to offer medical ...Learn More
Abbott enters systems integration deal with Diasend
A collaboration deal has been reached by Abbott and Diasend to allow a cloud-based connection between Abbott's LibreLink ...Learn More
Study shows positive results for Medtronic's leadless pacemaker
A study presented at a Cardiostim-EHRA Europace 2016 trial session showed positive results for Medtronic's leadless Micra ...Learn More
BrainScope seeks to develop new concussion diagnostic test
Bethesda, Md.-based BrainScope is developing a new iteration of its quantitative electroencephalography-based technology ...Learn More
Blood-drawing device from Seventh Sense could replace conventional methods
The TAP100 is a walnut-size device that can withdraw 100 microliters of blood using microneedles, does not produce much pain ...Learn More
Guidance for patient-specific device data sharing unveiled by FDA
A draft guidance has been released by the FDA to offer recommendations on how medical device makers can share ...Learn More
FDA clears screw fixation device from MX Orthopedics
MX Orthopedics has obtained clearance from the FDA for its dynaMX nitinol compression screw, a fixation device intended for ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
7th Annual Advertising and Promotion of Medical Devices Conference
Nov. 10-11 | Washington, D.C. ...Learn More
Confidence is contagious; so is lack of confidence.
Vince Lombardi, ...Learn More
Boston Scientific plans global restructuring of operations
Boston Scientific on Wednesday said it will implement a "global restructuring program" that is expected to bring up to $150 ...Learn More
Private placement pulls in $14.9M for AirXpanders
A private placement of almost 8.8 million shares has brought in $14.9 million for Palo Alto, Calif.-based AirXpanders. ...Learn More
Nevro revises target for public offering
An offering of convertible senior notes due in 2021 has been priced by Nevro in hopes of obtaining $150 million, up from the ...Learn More
Sensus Healthcare obtains $11M in IPO
An initial public offering of 2.3 million units has been completed by Sensus Healthcare with total proceeds of $11 million. ...Learn More
Avita Medical, Mintcare reach distribution deal
Singapore-based Mintcare has agreed to distribute UK-based Avita Medical's wound care offerings across the Asia-Pacific ...Learn More
Qiagen's offer to buy Exiqon extended for third time
Qiagen has reduced the acceptance threshold necessary to complete its $105 million acquisition of RNA analysis products ...Learn More
Trial begins for Medtronic's thoracic stent graft system
The first patient in a 100-patient trial of Medtronic's Valiant Evo thoracic stent graft system has received treatment with ...Learn More
Orthopedic surgery solutions unveiled by Flower Orthopedics
The Flower E-Kit and the IndicationCube have been launched by Flower Orthopedics. ...Learn More
FDA clears sample collection device from DNA Genotek
The FDA has given DNA Genotek, an OraSure Technologies subsidiary, 510(k) clearance for its ORAcollectDx collection device. ...Learn More
EU OKs Micro Interventional's transapical access and closure device
European regulators have given Newton, Pa.-based Micro Interventional Devices CE mark approval for the Permaseal, a ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
People seldom improve when they have no other model but themselves to copy.
Oliver Goldsmith, ...Learn More
LDR Holding to be acquired by Zimmer Biomet for $1.07B
Zimmer Biomet will acquire LDR Holding, a maker of devices and technologies for spine disorders, for $1.07 billion under a ...Learn More
Medtronic plans joint-replacement service with acquired startup
Medtronic plans to launch a joint-replacement service next year that will use knee and hip implants from Responsive ...Learn More
Investment firm gets $525M boost for life sciences fund
Life science investment firm Longitude Capital has secured $525 million for its Longitude Venture Partners III, its third ...Learn More
Funding round could bring in $125M for Nevro
An offering of convertible senior notes due in 2021 could pull in $125 million for Redwood City, Calif.-based Nevro. ...Learn More
Private placement pulls in $35M for Delcath
A private placement of senior convertible notes and stock purchase warrants has brought in $35 million for Queensbury, ...Learn More
Navy taps Battelle, Halyard for $14.4M conformal cover contract
Battelle and Halyard Health have secured a $14.4 million, four-year contract from the US Navy's Office of Naval Research, as ...Learn More
Study shows positive results for wearable artificial kidney
A study in JCI Insight showed promising results for a wearable artificial kidney developed by a team of doctors from the ...Learn More
Drug delivery system for chronic diseases debuted by Intarcia
The Medici Drug Delivery System, a platform of three technologies designed to provide constant drug delivery for treating ...Learn More
Cereve wins FDA clearance for insomnia treatment device
Pennsylvania-based Cereve has obtained clearance under the FDA's de novo program to market the Cereve Sleep System, a ...Learn More
ChoiceSpine's titanium lumbar fusion devices cleared by FDA
The FDA has given Knoxville, Tenn.-based ChoiceSpine clearance for its titanium lumbar interbody fusion devices. ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
PMA Submissions Workshop
Nov. 3-4 | Washington, D.C. ...Learn More
I'm not afraid of storms, for I'm learning how to sail my ship.
Louisa May Alcott, ...Learn More
NuVasive enters $98M deal to acquire Biotronic NeuroNetwork
NuVasive has reached a definitive agreement to pay $98 million in cash to acquire Biotronic NeuroNetwork, a neural ...Learn More
Funding round pulls in $1.4M for Medella Health
A round of funding has brought in $1.4 million for Canadian startup Medella Health, which is developing a smart contact lens ...Learn More
Surgical robot expected to bolster revenue for Medtronic
A robotic surgical system being developed by Medtronic is expected to generate "material revenue" for the company starting ...Learn More
Illumina, ArcherDx reach global distribution deal
Illumina has reached a nonexclusive agreement to distribute ArcherDx's FusionPlex oncology research products outside the US. ...Learn More
Quest Diagnostics plans to relocate headquarters in N.J.
Quest Diagnostics has announced plans to relocate its corporate headquarters from Madison, N.J., to Secaucus, N.J., and ...Learn More
St. Jude's heart failure system included in clinical practice guidelines
St. ...Learn More
Study shows positive results for Royal Philips' contactless pulse oximetry
A 41-patient study in Anesthesia & Analgesia showed positive results for Royal Philips' camera-based, contactless monitoring ...Learn More
EU OKs neuromodulation system from Axonics
European regulators have given Axonics Modulation Technologies CE mark approval for its Sacral Neuromodulation System, a ...Learn More
FDA panel to weigh change in use of Dexcom's glucose monitor
A public FDA advisory committee meeting is scheduled for next month to discuss whether Dexcom's G5 Mobile Continuous Glucose ...Learn More
Liquid biopsy test from Roche Molecular Diagnostics gets FDA approval
The FDA has given Roche Molecular Diagnostics approval for its cobas EGFR Mutation Test v2, the first liquid biopsy test ...Learn More
510(K) Submissions Workshop
Oct. 31-Nov. 1 | Washington, D.C. ...Learn More
IDE Submissions Workshop
Nov. ...Learn More
The greatest of faults, I should say, is to be conscious of none.
Thomas Carlyle, historian and ...Learn More
Offer for Exiqon's shares extended again by Qiagen
Qiagen extended for a second time its public tender offer for Exiqon's shares until June 20 after it received about 89% of ...Learn More
Private placement pulls in $21M for NeuroMetrix
A private placement of shares and warrants involving an institutional investor has brought in $21 million for Waltham, ...Learn More
Vital Connect gets $18M boost
A round of equity financing involving 27 unnamed investors has pulled in $18 million for Vital Connect, a maker of wearable ...Learn More
Novacyt closes $1.6M funding round, Primer Design purchase
A private equity placement has brought in $1.6 million for cancer and infectious disease diagnostics company Novacyt. ...Learn More
Illumina, ArcherDX reach co-development deal
A co-development agreement has been reached by ArcherDX and Illumina to create a series of next-generation sequencing-based ...Learn More
Texas Medical Center accelerator showcases startups in digital health
The Texas Medical Center last week introduced 12 digital health care startups that are part of its TMCx business ...Learn More
Trial begins for Intact Vascular's endovascular system
A 200-patient, multisite clinical trial has been launched by Wayne, Pa.-based Intact Vascular to assess its Tack ...Learn More
3D-printed implant from N.J. startup cleared by FDA
Little Silver, N.J.-based Additive Orthopaedics has obtained 510(k) clearance from the FDA for its first product, a ...Learn More
Commentary: Device tax suspension provides wide-ranging benefits for Ohio
The suspension of the medical device tax has helped medtech innovation continue, allowing manufacturers in Ohio to expand ...Learn More
EU OKs Occlutech's left atrial appendix occluder
The Left Atrial Appendix Occluder by Occlutech has been given CE mark approval by European regulators. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
Failure makes success so much sweeter, and allows you to thumb your nose at the crowds.
Wilbur Smith, ...Learn More
IPO brings in $50M for Clearside Biomedical
An upsized initial public offering of 7.2 million shares has brought in $50 million for Alpharetta, Ga.-based Clearside ...Learn More
Alere expects merger with Abbott to close as planned
Alere said it is fully abiding by the terms of its merger agreement with Abbott Laboratories and that it expects the ...Learn More
Sensus Healthcare obtains $11M in IPO
An initial public offering of 2 million units has pulled in $11 million for Sensus Healthcare. ...Learn More
Funding round pulls in $5.2M for Wash. ultrasound device developer
A round of debt financing involving three unnamed investors has brought in $5.2 million for Bothell, Wash.-based Mirabilis ...Learn More
Report predicts growth for global neurology devices market
A Grand View Research report predicts the worldwide market for neurology devices will hit $10.8 billion by 2022. ...Learn More
New CEO, board member named by CardioDX
Khush Mehta, former global head of the health care enterprise solutions division at Siemens Healthcare, has been tapped to ...Learn More
Study shows positive results for Abbott's nitinol stent
A 97-patient study in the Journal of Endovascular Therapy showed positive results for Abbott Vascular's Supera interwoven ...Learn More
Lumbar interbody fusion device debuted by Pinnacle Spine
The InFill Anterior Lumbar Interbody Fusion device has been launched by Dallas-based Pinnacle Spine Group as an addition to ...Learn More
EU approves stent graft from W.L. Gore
European regulators have given W.L. Gore & Associates CE mark approval for its Excluder conformable device. ...Learn More
FDA clears First Ray's transosseous fixation system
The FDA has granted First Ray clearance for its SpeedButton system. ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
The successful warrior is the average man, with laserlike focus.
Bruce Lee, martial artist, actor and ...Learn More
Medtronic plans shake-up of restorative therapies group
Medtronic on Tuesday said it will reorganize its restorative therapies group by shifting focus from technology to diseases ...Learn More
Funding round pulls in $25M for EarlySense
A round of Series G funding has brought in $25 million for Israeli medical device company EarlySense. ...Learn More
Offering brings in $19.8M for Second Sight
An oversubscribed rights offering has pulled in $19.8 million for Sylmar, Calif.-based Second Sight Medical. ...Learn More
Anthem to cover Exact Sciences' colon cancer screening test
Anthem Blue Cross and Blue Shield has agreed to cover the Cologuard colon cancer screening test from Exact Sciences. ...Learn More
Royal Philips, Yale create interventional oncology research program
A master research agreement between Royal Philips and the Yale School of Medicine has been expanded to include a multiyear ...Learn More
More drug, device makers agree to risk-sharing
As payers and health care providers push back against the cost of drugs and devices, manufacturers are responding with new ...Learn More
Roche's self-testing device for coagulation released in Europe
The CoaguChek INRange system has been launched by Roche Diagnostics in Europe for use in self-monitoring of blood ...Learn More
FDA issues updated IDE categorization policies for CMS coverage decisions
A draft guidance has been issued by the FDA to update its guidelines for categorizing investigational medical devices and ...Learn More
EU OKs vascular access system from Avenu Medical
European regulators have given Avenu Medical approval for its Ellipsys vascular access image-guided catheter system. ...Learn More
FDA clears interbody systems from K2M
The FDA has granted K2M 510(k) clearance for its CASCADIA Cervical and CASCADIA AN Lordotic Oblique Interbody Systems, which ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
You don't always win, but every time you lose, you get better.
Ian Somerhalder, ...Learn More
Boston venture capital firm secures $274M for sixth life sciences fund
SV Life Sciences, a Boston-based venture capital firm that invests in medical device, health care services and biotech ...Learn More
EndoPredict maker Sividon acquired by Myriad
Myriad Genetics agreed to pay $39 million plus milestone payments of up to $17 million for Sividon Diagnostics. ...Learn More
Spine Wave gets $11M boost
Shelton, Conn.-based Spine Wave has raised $11 million in a round of financing involving 30 investors. ...Learn More
Private placement brings in $3.4M for Arch Therapeutics
A private placement of common stock and warrants has pulled in $3.4 million for Framingham, Mass.-based Arch Therapeutics. ...Learn More
Aurora Spine obtains about $385K in private placement
A private placement of 2.53 million common shares has brought in about $385,000 for Aurora Spine. ...Learn More
Qiagen teams up with CareDx on HLA typing product
A collaboration deal has been struck by Qiagen and CareDx to combine Qiagen's QIAxcel Advanced automated capillary ...Learn More
First real-world use of wound-plugging device recorded by RevMedx
A soldier suffering a gunshot wound to his left thigh was the first to receive a treatment using RevMedx's XSTAT Rapid ...Learn More
Bioventrix gets IDE approval for transcatheter ventricular enhancement device
The FDA has given Bioventrix an investigational device exemption to conduct a pivotal trial of its Revivent TC TransCatheter ...Learn More
Handheld blood test debuted by Royal Philips
The Minicare I-20 system, a handheld blood test intended to provide point-of-care diagnosis of a heart attack, has been ...Learn More
Australia clears interbody products from Tyber Medical
Orthopedic systems maker Tyber Medical said its entire portfolio of interbody products has been accepted in the Australian ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Growth is an erratic forward movement: two steps forward, one step back. Remember that and be very gentle with yourself.
Julia Cameron, writer and ...Learn More
Bill would streamline CMS coverage decisions for breakthrough medtech
A measure that would enable CMS to provide immediate transitional coverage for breakthrough medical technologies that have ...Learn More
For more:
Read the AdvaMed press release in support of the Ensuring Patient Access to Critical Breakthrough Products Act introduced in ...Learn More
Thermo Fisher enters $4.2B deal to acquire Ore. microscopy specialist
Waltham, Mass.-based Thermo Fisher Scientific has entered into an agreement to acquire FEI, a Hillsboro, Ore.-based electron ...Learn More
Life sciences venture fund raises $285M for 5th fund
5AM Ventures raised $285 million for early-stage and seed investments in life science startups. ...Learn More
EQT medical device unit sold to European private equity firm
EQT on Monday announced that private equity firm PAI Europe bought its medical device unit Atos Medical, a maker of voice ...Learn More
Nephros, CS Medical reach distribution deal
An agreement has been formed between CS Medical and Nephros to distribute the latter's DSU-H ultrafilter as an offering with ...Learn More
New senior surgical officer named at TransEnterix
Theodore Pappas, a surgeon with the Duke University Health System and a distinguished professor of surgical innovation at ...Learn More
Whitaker: Radiotherapy is vital in global battle against cancer
Radiation therapy is a cost-effective cancer treatment that provides clinical benefits for patients and economic advantages ...Learn More
First procedure using gastroesophageal device recorded by EndoGastric
A patient at University of California Irvine Health was the first to undergo a transoral incisionless fundoplication ...Learn More
Quest Diagnostics' Zika virus test now available in Fla.
Quest Diagnostics' Zika Virus RNA Qualitative Real-Time RT-PCR screening test, the first commercial Zika virus blood ...Learn More
FDA clears miniprobes from Mauna Kea
The FDA has given French medical device firm Mauna Kea Technologies clearance for its Confocal Miniprobes, indicated for use ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Experience is a hard teacher because she gives the test first, the lesson afterward.
Vern Law, baseball ...Learn More
Phase-in of DMEPOS fees should be delayed, AdvaMed, stakeholders tell Congress
Congressional leaders received a letter this week from nine national organizations, including AdvaMed, and 24 state ...Learn More
For more:
Read AdvaMed's news release supporting the Patient Access to Durable Medical Equipment ...Learn More
Financing round pulls in $51.2M for TransMedics
A round of equity funding has brought in $51.2 million for Andover, Mass.-based TransMedics. ...Learn More
Offering could bring in $6M for Great Basin Scientific
A public offering of 3.16 million units of common stock and warrants has been priced by Salt Lake City-based Great Basin ...Learn More
Life sciences startups secure $750K loans from Mass. agency
The Massachusetts Life Sciences Center has given orthopedic device maker MX Orthopedics and diagnostic product developer ...Learn More
Report predicts growth for global hip, knee orthopedic surgical implants market
A Medical Market Research report predicts the worldwide market for hip and knee orthopedic surgical implants will hit $34.57 ...Learn More
Study shows positive results for Endologix's endovascular system
A prospective, single-arm study that included 150 patients at 30 US and European sites showed positive results for ...Learn More
Experimental devices could allow in situ cancer cell analysis
An endoscope and a 3D imaging device, both based on multiphoton excited fluorescence microscopy, may accelerate diagnosis ...Learn More
Cell sorting system unveiled by Becton Dickinson
The FACSMelody system has been introduced by Becton Dickinson as an addition to its portfolio of cell sorters. ...Learn More
Drug-delivering implant to treat opioid addiction approved by FDA
The FDA on Thursday granted Braeburn Pharmaceuticals and Titan Pharmaceuticals approval for Probuphine, a first-of-its-kind, ...Learn More
EU expands approval for esophageal cooling device
European regulators have given Chicago-based Advanced Cooling Therapy expanded CE mark approval extending the use of its ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
SmartBrief will not publish Monday
In observance of Memorial Day in the US, SmartBrief will not publish Monday. Publication will resume ...Learn More
It's the curiosity that drives me. It's making a difference in the world that prevents me from ever giving up.
Deborah Meier, ...Learn More
Medtronic, Qualcomm Life partner to develop next-gen glucose monitors
Medtronic announced Wednesday that it is teaming up with Qualcomm Life, a subsidiary of digital communications company ...Learn More
Canada-based Alere unit launches $8.1M expansion project
Epocal, an Alere subsidiary that manufactures wireless-enabled blood diagnostic platforms, has announced an $8.1 million ...Learn More
Funding round pulls in $1.5M for CardioNXT
A round of equity funding has brought in $1.5 million for Westminster, Colo.-based medtech company CardioNXT. ...Learn More
Senseonics, Roche reach distribution deal on glucose monitor
A deal has been reached between Senseonics and Roche Holding to allow the latter to exclusively distribute Senseonics' ...Learn More
Asia-Pacific distribution negotiation for surgical system extended by Titan Medical
Titan Medical said its negotiations with Longtai Medical to exclusively distribute Titan's Sport Surgical System in the ...Learn More
Tiny animal-tissue robot could be used for GI procedures
Massachusetts Institute of Technology researchers have developed a concept for a tiny robot that could be swallowed, unfold ...Learn More
Neurostimulator from Mainstay Medical wins EU approval
European regulators have given Dublin-based Mainstay Medical CE mark approval for its ReActiv8 neurostimulator, a device ...Learn More
FDA, EU clear hybrid fixation implant from Implanet
The FDA has given Implanet clearance for the Jazz Claw, a hybrid implant indicated for treating adults with complex ...Learn More
Australia OKs diagnostic instrument from Illumina
The Australian Therapeutic Goods Administration has cleared the MiSeqDx instrument from Illumina for clinical use. ...Learn More
Cytomegalovirus test approved for use in stem cell transplant recipients
Roche Holding's in vitro diagnostic assay for cytomegalovirus has been approved by the FDA for use in patients who receive ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
Striving for success without hard work is like trying to harvest where you haven't planted.
David Bly, ...Learn More
IPO could bring in $13M for Viveve
An initial public offering of almost 1.6 million shares has been priced by Sunnyvale, Calif.-based Viveve in hopes of ...Learn More
Funding round pulls in $12M for Zebra Medical Vision
A round of funding has brought in $12 million for Zebra Medical Vision, an Israel-based startup that develops big-data ...Learn More
U. of Pittsburgh taps InCube Labs for $10M DOD subcontract
The University of Pittsburgh has awarded San Antonio-based InCube Labs a $10 million subcontract to help develop an ...Learn More
Financing round brings in $5.2M for BrightWater Medical
A round of Series A financing has brought in $5.2 million for Mountain View, Calif.-based ureteral medical device maker ...Learn More
Propeller Health to develop inhaler sensor with Vectura
Madison, Wis.-based Propeller Health has signed a partnership with UK-based Vectura Group to create an add-on sensor that ...Learn More
New corporate secretary, CFO named by Entellus Medical
Brent Moen, who has over 25 years of experience in finance, has been tapped to serve as corporate secretary and chief ...Learn More
Study shows positive results for Covidien's stent retriever
A study in the journal Radiology showed positive results for the Solitaire device, a stent retriever developed by Covidien, ...Learn More
Cardiac pacing device monitor from Biotronik debuts in US
The CardioMessenger Smart, a portable monitoring device that allows for remote connectivity of insertable cardiac monitors, ...Learn More
FDA panel backs St. Jude Medical's cardiac implant
An FDA panel has voted in favor of approving St. ...Learn More
Interbody fusion device from Interventional Spine cleared by FDA
The FDA has given Interventional Spine clearance for its 8-degree Lumbar Lordotic Opticage Expandable Intervertebral Body ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
If you're not reaching back to help anyone, then you're not building a legacy.
Germany Kent, media ...Learn More
Luminex raises bid for Nanosphere to about $77M
Luminex has increased its bid to acquire Nanosphere from $1.35 per share to $1.70 per share, raising the deal's value from ...Learn More
Offering of Wright Medical shares could pull in $120M
A secondary offering of 6.2 million shares has been announced by Wright Medical in hopes of raising up to $120 million. ...Learn More
Varian Medical's imaging component unit to be spun off this year
Varian Medical on Monday announced plans to split off its imaging components business into a standalone public entity using ...Learn More
Offering could pull in $500M for Quest Diagnostics
Quest Diagnostics has unveiled a plan to raise $500 million in a public offering of senior notes. ...Learn More
Global health care wearable devices market to reach $18.9B in 2020
A Frost & Sullivan analysis predicts the global market for health care wearable devices will reach $18.9 billion in 2020, at ...Learn More
ENDRA teams up with GE Healthcare to develop ultrasound technology
GE Healthcare and ENDRA Life Sciences are forming a partnership to develop the latter's Thermo Acoustic Enhanced UltraSound ...Learn More
Data show positive results for Baxter's dialyser
Data from abstracts presented at the European Renal Association and European Dialysis and Transplant Association's 53rd ...Learn More
Bone autograft extender unveiled by NuVasive
AttraX putty has been introduced in the US by San Diego-based NuVasive as an addition to its biologics portfolio. ...Learn More
Reusable colonoscopy device from Avantis cleared by FDA
Avantis Medical Systems has obtained clearance from the FDA for its Third Eye Panoramic as a reusable device for ...Learn More
FDA clears single-use endoscope valves from EndoChoice
The FDA has given Alpharetta, Ga.-based EndoChoice 510(k) clearance for its sterile, disposable air/water and suction valves ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
Life is bristling with thorns, and I know no other remedy than to cultivate one's garden.
Voltaire, writer and ...Learn More
J&J robot-assisted surgery unit to move into product design
Johnson & Johnson officials told investors last week that the company's robot-assisted surgery unit, Verb Surgical, will ...Learn More
Offering could pull in $5M for Cancer Genetics
A direct offering of common stock and warrants could bring in $5 million for Rutherford, N.J.-based diagnostics company ...Learn More
Empire Genomics gets $1.75M boost
A round of follow-on financing led by investor BroadOak Capital Partners has brought in $1.75 million for Buffalo, ...Learn More
Mass. agency to support life sciences projects through capital program
A capital program with up to $35 million in funding will be launched this month by the Massachusetts Life Sciences Center ...Learn More
NovoCure names executive chairman
William Doyle will become the executive chairman of NovoCure under a deal signed with the company earlier this month. ...Learn More
First US procedure using meniscus implant recorded by Active Implants
A patient at Salt Lake Regional Medical Center in Utah was the first in the US to undergo meniscus replacement using Active ...Learn More
Gastrointestinal aspiration needle unveiled by Olympus
The EZ Shot 3 Plus needle has been introduced by Olympus as an addition to its gastrointestinal portfolio. ...Learn More
EU OKs drug-eluting balloon from iVascular
European regulators have given Spanish coronary and endovascular device maker iVascular CE mark approval for its Luminor 18 ...Learn More
Roche's in vitro test wins approval from FDA
Roche Holding has obtained approval from the FDA for its Ventana PD-L1 assay, which assesses PD-L1 status in patients with ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
One of the greatest regrets in life is being what others would want you to be, rather than being yourself.
Shannon Alder, ...Learn More
Royal Philips, S.C. health care provider reach $36M long-term deal
An eight-year partnership valued at $36 million has been signed by Royal Philips and Medical University of South Carolina ...Learn More
J&J, HP unit team up, aim to improve health care outcomes through 3D printing
Johnson & Johnson has partnered with an HP unit in an effort to improve health care outcomes at lower costs by using ...Learn More
Funding round pulls in $1.7M for Bone Solutions
A private placement has brought in $1.7 million for Dallas-based Bone Solutions, weeks before it intends to launch its ...Learn More
Report predicts growth for worldwide medical imaging market
An Allied Market Research report predicts the global medical imaging market will see a compound annual growth rate of 5% ...Learn More
New CEO, president named by Flowonix Medical
Larry Heaton, former CEO, president and director of Cardiox, has been tapped to serve as CEO and president of Flowonix ...Learn More
Registry completed to test NinePoint Medical's endomicroscopy system
The primary phase of a registry investigating the use of NinePoint Medical's NvisionVLE Imaging System in high-resolution ...Learn More
First surgery using robotic spinal surgery system in Spain recorded by Medtech
A patient with degenerative disc disease at La Fe Hospital of Valencia was the first in Spain to undergo a spine surgery ...Learn More
Platform for cervical spine fusions launched by Medtronic
Spine Essentials, a kit of implants and instruments designed for streamlining one- and two-level cervical spine fusion ...Learn More
Patient-controlled infusion system debuted by Hospira
The LifeCare PCA 7.0 Infusion System has been introduced by Pfizer subsidiary Hospira for improving pain management ...Learn More
Boston Scientific wins FDA approval for spinal cord stimulator
The FDA has granted Boston Scientific approval for its Precision Montage MRI-safe spinal cord stimulator system, which ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Unless you try to do something beyond what you have already mastered, you will never grow.
Ronald Osborn, teacher and ...Learn More
Medtronic announces deals with Smith & Nephew, Mazor Robotics
Medtronic has reached a $350 million agreement with Smith & Nephew to acquire the latter's gynecology unit that offers ...Learn More
Offering brings in $400M for Teleflex
Wayne, Pa.-based Teleflex has raised $400 million, before underwriting commissions and discounts, from an offering of senior ...Learn More
Pulse Biosciences obtains $20M from offering
An initial public offering of 5 million shares has pulled in $20 million for Pulse Biosciences. ...Learn More
Funding round pulls in $4.5M for Decisio Health
A round of Series B funding led by DECLATEX has brought in $4.5 million for Decisio Health. ...Learn More
Report predicts growth for global diagnostic imaging market
A P&S Market Research report predicts the worldwide diagnostic imaging market will see a compound annual growth rate of 5% ...Learn More
New president, CEO named by EndoStim
Rohan Hoare, former president of Salient Medical, has been tapped to serve as president and CEO of St. Louis-based EndoStim. ...Learn More
Lung perfusion device studied in US
The XPS device developed by Sweden's XVIVO Perfusion is being studied for the conditioning of donor lungs in clinical trials ...Learn More
St. Jude Medical launches fractional flow reserve system in Europe
The PressureWire X Guidewire fractional flow reserve measurement system is being launched by St. ...Learn More
CMS begins coverage analysis for leadless pacemakers
The CMS has released a memo initiating an analysis of whether it should provide national coverage for leadless pacemakers. ...Learn More
Siemens' tomosynthesis platform wins FDA approval for 3D-only breast screening
The FDA has given Siemens Healthineers approval to use its Mammomat Inspiration with Tomosynthesis Option as a standalone, ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
Diligence is the mother of good fortune.
Miguel de Cervantes, ...Learn More
German diagnostics firm sold to Siemens Healthineers
NEO New Oncology, a cancer diagnostics firm based in Germany, has been acquired by Siemens Healthineers for undisclosed ...Learn More
Singulex gets $50M boost from Grifols
Singulex, a developer of clinical diagnostic technologies, has received a $50 million investment from Grifols, which gives ...Learn More
Funding round brings in $40M for Mitralign
A round of Series E financing has brought in almost $40 million for Tewksbury, Mass.-based Mitralign. ...Learn More
Royal Philips, Profound team up to market ultrasound ablation system
Royal Philips and Profound Medical have expanded their existing collaboration through a deal to commercialize the latter's ...Learn More
11 medtech startups chosen to join Fla. accelerator program
GuideWell and Healthbox have named 11 early-stage medtech firms that will take part in a Florida–based accelerator ...Learn More
Report predicts growth for global portable ultrasound market
A P&S Market Research report predicts the worldwide market for portable ultrasound devices will see a compound annual growth ...Learn More
Studies show positive results for Brainsway's magnetic brain stimulation device
Studies presented at the American Psychiatric Association 2016 Annual Meeting showed positive results for Brainsway's Deep ...Learn More
CardioFocus to launch laser ablation catheter in select US markets
The HeartLight laser ablation catheter is expected to be released by CardioFocus on a limited basis in the US by July. ...Learn More
FDA clears osteoporosis diagnostics device from Bone Index
The FDA has given Finland-based Bone Index 510(k) clearance for its point-of-care device called Bindex. ...Learn More
FDA clears bone fixation device from First Ray
Surgical Frontiers startup First Ray has obtained 510(k) clearance from the FDA for its CortiClamp System. ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
MedTech Compliance 201: A Deeper Dive into the Compliance Landscape
Sept. 21 | AdvaMed office, Washington, D.C. ...Learn More
The man who moves a mountain begins by carrying away small stones.
Confucius, philosopher and ...Learn More
Luminex signs deal to buy Nanosphere
Luminex agreed to pay $58 million plus $25 million in debt to acquire Nanosphere, an Illinois-based firm that produces ...Learn More
Funding round pulls in $30M for Impulse Dynamics
A round of funding has brought in $30 million for German medtech firm Impulse Dynamics. ...Learn More
Deal to buy Cayenne Medical finalized by Zimmer Biomet
The acquisition of Arizona-based Cayenne Medical, a maker of soft tissue repair and reconstruction solutions for the ...Learn More
ReCor, Otsuka enter deal to market renal denervation device in Asia
Japan-based conglomerate Otsuka Pharmaceutical has made a deal to exclusively conduct trials, seek regulatory approval and ...Learn More
Delphinus moves its headquarters in Mich.
The corporate headquarters for Delphinus Medical Technologies, a developer of tomographic ultrasound, are being moved from ...Learn More
First human implanted with micro-anchor heart device recorded by BioVentrix
A patient at Vilnius University Hospital in Lithuania was the first human to be implanted with the Revivent device from San ...Learn More
Stented tissue heart valve introduced by St. Jude Medical
The Trifecta GT stented tissue valve has been released by St. ...Learn More
AdvaMed raises concerns about India's medical device regulation
Although the implementation of the SUGAM governance system has enabled online filing, tracking and approval of applications, ...Learn More
FDA clears EndoGastric Solutions' gastroesophageal barrier device
EndoGastric Solutions has obtained 510(k) clearance from the FDA for its EsophyX Z device, which is intended for providing ...Learn More
Interbody spacer system from Orthofix cleared by FDA
Orthofix has received clearance from the FDA for its FORZA PEEK Titanium Composite Spacer System. ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
It is not enough that we do our best; sometimes we must do what is required.
Winston Churchill, former British prime ...Learn More
Wright Medical gets $395M boost
A private placement of convertible senior notes involving a syndicate of investors has brought in $395 million for Wright ...Learn More
Deal to acquire VirtualScopics finalized by BioTelemetry
The acquisition of clinical trial imaging firm VirtualScopics, valued at $15.5 million, has been completed by BioTelemetry, ...Learn More
Waters obtains $250M from private placement
A private placement of senior notes worth $250 million has been completed by Waters, according to a filing with the SEC. ...Learn More
Funding round brings in $12M for ExThera Medical
A round of Series A financing has pulled in $12 million for Martinez, Calif.-based ExThera Medical, with $491,018 remaining ...Learn More
Public offering could pull in $11M for Sensus Healthcare
An initial public offering of 1.8 million units of common shares and warrants has been refiled by Boca Raton, Fla.-based ...Learn More
Initial cases using interbody system recorded by Life Spine
Initial surgical procedures using the PROLIFT Expandable Interbody System have been completed by Huntley, Ill.-based Life ...Learn More
SI-BONE partners with Yale University to share clinical trial results
SI-BONE has agreed to share clinical trial data with the Yale University Open Data Access Project, whose mission is to ...Learn More
Final guidance on postmarket device surveillance released by FDA
The FDA has issued final guidance to help medical device manufacturers comply with postmarket surveillance orders for ...Learn More
FDA issues draft guidance on infectious disease NGS Dx devices
Draft guidance has been released by the FDA to provide recommendations on designing validation studies for next-generation ...Learn More
New indication for Xtant Medical's spinal fixation system cleared by FDA
The FDA has given Xtant Medical clearance to a add posterior cervical screw indication for its Certex Spinal Fixation ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Mistakes are the growing pains of wisdom.
William George Jordan, writer and ...Learn More
Offering could bring in $400M for Teleflex
An offering of senior notes has been priced by Wayne, Pa.-based Teleflex in hopes of obtaining $400 million. ...Learn More
EndoStim obtains $25M from financing round
A round of Series D financing led by Switzerland-based investor Endeavour Vision has brought in $25 million for St. ...Learn More
Private placement could pull in $10.4M for OpGen
A private placement of common stock and warrants that could raise $10.4 million has been announced by Gaithersburg, ...Learn More
Amarantus, Theranostics acquisitions finalized by Avant
The acquisitions of Amarantus Diagnostics and Theranostics Health have been completed by Scottsdale, Ariz.-based Avant ...Learn More
Cardinal Health enters deal to market stents from Biosensors
Cardinal Health has agreed to allow Cordis, its interventional vascular business, to distribute Biosensors' coronary stent ...Learn More
Median Technologies to unveil Mass. facility next week
Median Technologies, a France-based medical imaging software company, will open a facility in Woburn, Mass., on May 16. ...Learn More
Study shows positive results for Boston Scientific's heart device
A 150-patient, four-site study in the Journal of the American College of Cardiology showed positive results for Boston ...Learn More
Uterine tissue removal system unveiled by Hologic
The MyoSure REACH, a system intended for preventing abnormal uterine bleeding through the removal of polyps and fibroids, ...Learn More
EU OKs atrial decompression device from Corvia Medical
European regulators have given Corvia Medical approval for its InterAtrial Shunt Device, which is intended for treating ...Learn More
Camber's anterior interbody fusion system cleared by FDA
The FDA has granted Camber Spine Technologies 510(k) clearance for its ENZA Zero Profile Anterior Interbody Fusion system, ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
MedTech Compliance 101: Boot Camp
Sept. 19-20 | AdvaMed office, Washington, D.C. ...Learn More
The only way you are going to have success is to have lots of failures first.
Sergey Brin, computer scientist and ...Learn More
Funding round pulls in $8M for NeuSpera Medical
A round of equity financing involving three anonymous investors has brought in $8 million for Santa Clara, Calif.-based ...Learn More
J&J life sciences incubator launches in Toronto
Johnson & Johnson Innovation has launched its sixth JLABS facility, which is located in Toronto and has 22 participating ...Learn More
BioDiscovery to provide software for Illumina's NGS assay
Illumina has entered into a deal with BioDiscovery to use the latter's NxClinical data visualization software as a tool for ...Learn More
Report: Global neurology devices market poised for growth
A Grand View Research report predicts the worldwide market for neurology devices will hit $10.8 billion by 2022. ...Learn More
New CFO, chief compliance officer named by GI Dynamics
Jim Murphy, former chief financial officer at Oxigene and HemaSure, has been chosen to serve as chief financial officer of ...Learn More
First surgeries using spine surgical range recorded by Safe Orthopaedics
Patients in France and Switzerland were the first to undergo surgeries using the SteriSpineCC range from Safe Orthopaedics. ...Learn More
Real-time feature of NinePoint's imaging system cleared by FDA
NinePoint Medical has obtained 510(k) clearance from the FDA to market the real-time targeting feature of its NvisionVLE ...Learn More
Trunzo: Breakthrough medtech bill would strengthen patient access to treatments
A bill establishing a priority review process for breakthrough medical technologies has gained wide bipartisan support in ...Learn More
Right to Try bill introduced in Senate
Legislation that would enable terminally ill patients to gain access to experimental treatments or devices that are still ...Learn More
Lungpacer's diaphragm pacing system wins expedited access status from FDA
The FDA has given Lungpacer Medical, a maker of neurostimulation systems for diaphragm muscle complications, Expedited ...Learn More
Compliance Executive Speaker Series
May 18 | Sunnyvale, Calif.Participants will have the opportunity to dissect some of the most pressing legal and compliance ...Learn More
Women's Leadership Development Conference
June 15 | Washington, D.C. Join us on June 15 in Washington. ...Learn More
The only strategy that is guaranteed to fail is not taking risks.
Mark Zuckerberg, ...Learn More
Senate committee issues report on physician-owned distributorships
A report was released by the Senate Finance Committee recommending stricter transparency laws and hospital policies to ...Learn More
For more:
Read the news release in which AdvaMed applauds the Senate Finance Committee for its report on physician-owned ...Learn More
BioMedical Enterprises sold to DePuy unit
BioMedical Enterprises, a maker of nitinol orthopedic implants for treating deformities of the foot, ankle, hand and wrist, ...Learn More
BioTelemetry completes tender offer for VirtualScopics shares
A tender offer for all outstanding common and preferred shares of VirtualScopics, a clinical trial imaging company, was ...Learn More
GE, Heritage Valley reach imaging managed equipment service deal
A 14-year deal has been reached by GE Healthcare to bring MRI and CT scanners, as well as ultrasound equipment, to Heritage ...Learn More
Roche expects diabetes-testing business to grow
Roche Holding expects to see its diabetes-testing business rebound in 2017 and has no plans to sell off the unit despite ...Learn More
Studies show positive results for NeoTract's enlarged prostate treatment
Two studies presented at the annual American Urological Association meeting in San Diego showed positive results for ...Learn More
Spinal surgery device to be unveiled by SpineGuard
The PediGuard Threaded device is expected to be launched next week by Paris-based SpineGuard at the SpineWeek 2016 ...Learn More
Commentary: Medical device tax suspension promotes N.Y. medtech innovation
The medical technology industry in New York continues to save and improve the lives of people around the world through ...Learn More
EU OKs continuous glucose monitor from Senseonics
European regulators have given Senseonics CE mark approval for its Eversense continuous glucose monitoring system. ...Learn More
South Korea OKs sequencing instruments from Illumina
South Korea's Ministry of Food and Drug Safety has approved Illumina's MiSeqDx instrument and MiSeqDx Universal kit for ...Learn More
Executive Communications Skill Building Workshop
May 16 | Minneapolis, Minn. ...Learn More
Integrating Human Factors into Medical Device Design Control and Beyond Workshop
June 7-8 | Golden Valley, Minn.Maintaining effective design control procedures is a key element of the quality system ...Learn More
You live but once; you might as well be amusing.
Coco Chanel, fashion ...Learn More
DOD taps Masimo for $36M pulse oximeters contract
The Department of Defense has awarded Masimo a five-year contract valued at almost $36 million to provide the Army, Marine ...Learn More
Siemens creates MR fingerprinting partnership with Case Western
Siemens Healthineers and Case Western Reserve University are teaming up to explore magnetic resonance fingerprinting, a ...Learn More
Greatbatch, WiTricity expand partnership on wireless energy transfer technology
A licensing and collaboration agreement between Greatbatch and Watertown, Mass.-based WiTricity has been expanded to apply ...Learn More
Global ultrasound market poised for growth, research firm says
P&S Market Research predicts the worldwide ultrasound market will see a compound annual growth rate of 5.5% through 2022. ...Learn More
Aetna covers breast cancer test from NanoString
NanoString Technologies has received a positive coverage decision from Aetna for Prosigna, a test for evaluating the ...Learn More
New CEO, board member named by Personal Genome Diagnostics
Douglas Ward has been chosen to serve as CEO and a member of the board of directors at Baltimore-based Personal Genome ...Learn More
Study shows positive results for Boston Scientific's S-ICD system
A 994-patient, 42-site study presented at the Heart Rhythm Society's scientific sessions in San Francisco showed positive ...Learn More
Sacroiliac joint fusion system unveiled by CoreLink
The Entasis Sacroiliac Joint Fusion System has been introduced by CoreLink, a US maker of spinal implants. ...Learn More
3D printing guidance for medical devices released by FDA
Draft guidance has been published by the FDA to provide medical device makers with initial thoughts on technological ...Learn More
EU OKs collagen corneal shields from Oasis Medical
European regulators have given Glendora, Calif.-based Oasis Medical CE mark approval for its Soft Shield collagen corneal ...Learn More
Reimbursement 101: A Primer on Medical Device Reimbursement
June 28-29 | San Francisco, Calif.During this workshop, you will be provided with the road map and practical applications to ...Learn More
Reimbursement 201: A Deeper Dive into the Reimbursement Landscape
June 29-30 | San Francisco, Calif.This next-level reimbursement workshop was created with the more advanced professional in ...Learn More
Correction
A headline in Monday's brief provided the wrong name for the company acquiring Galil Medical. ...Learn More
If you want to gather honey, don't kick over the beehive.
Dale Carnegie, writer and ...Learn More


sign up
for a daily briefing on top stories in the medical technology and diagnostics industries, FREE
In the News
Ex-Duke football player: How I had my heart attack (and what you can learn from it)
By: Fox News | July 2016

Heart disease is the number one cause of death for both men and women in the United States. Claiming approximately 1 million lives per year, heart attacks alone strike someone every 43 seconds. On January 20, 2014, that someone was me. 

Learn More
Fighting prostate cancer: Treatments evolve, from robotic surgery to hormonal therapy
By: NJ.com | June 2016

Robotic prostatectomy with the da Vinci is one of the latest surgical innovations used to treat prostate cancer.  

Learn More
Confronting A Global Radiotherapy Shortfall
By: Med Device Online | May 2016

As much as 60 percent of the world’s population does not have access to a cost-effective form of cancer treatment and management therapy that saves lives and improves clinical outcomes. 

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

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

Learn More


Twitter FeedTwitter
Twitter
@ AdvaMedUpdate