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Teleflex taps Kelly to succeed Smith as CEO | Personnel Moves – March 1, 2017
Teleflex (NYSE:TFX) said this month that CEO Benson Smith will retire from the corner office by the end of this calendar year. Smith will continue to serve as the company’s chairman of the board. Liam...
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FDA clears CeloNova’s Cobra PzF coronary stent
CeloNova BioSciences said today it won FDA approval for its Cobra PzF nanocoated coronary stent system. The device is now cleared with indications for improving coronary luminal diameter in patients...
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Penumbra shares rise on whopping Q4, FY2016 earnings beat
Shares in Penumbra (NYSE:PEN) have soared today after the medical device maker topped expectations on Wall Street with its 4th quarter and fiscal year 2016 earnings results. The Alameda, Calif.-based...
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FDA releases January 2017 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD January 2017 TOTAL 510(k)s THIS PERIOD 222 TOTAL WITH SUMMARIES 203 TOTAL WITH STATEMENTS 19 DEVICE: Love Alchemy's...
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Medtech IoT: We need to talk about what is happening in middleware
[Image courtesy of brykmantra via Flickr, per Creative Commons license.]Middleware could be the key when it comes to discussing how the Internet of Things is going to succeed in medtech. In the most...
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Trump calls for speedier approval process, while Sanders takes aim at drug...
In his 1st address to Congress, President Donald Trump called for speeding up drug approvals within the FDA. Earlier that day, Sen. Bernie Sanders (I-Vermont) proposed a bill to allow the importation...
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MassDevice.com +5 | The top 5 medtech stories for March 1, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Aerie resubmits NDA for Rhopressa eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year,...
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Solace Therapeutics says 3rd trial of Vesair bladder device met endpoints
Solace Therapeutics today released data from a trial of its Vesair bladder control device, touting that the study met its endpoints “with statistical significance.” The Framingham, Mass.-based...
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NxStage shares lift on Q4, FY2016 earnings release
Shares in NxStage Medical (NSDQ:NXTM) rose today after the medical device maker met expectations on Wall Street with its 4th quarter and full year 2016 earnings results. The Lawrence, Mass.-based...
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CardioFocus raises $20m, looking for $12m more
CardioFocus raised $20.2 million in a new round of equity and options financing, according to an SEC filing posted this week. Money in the round came from 26 unnamed investors, with the first sale...
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Micro Interventional Devices touts 2nd valve repair with Mia device trial
Micro Interventional Devices said today it completed the 2nd successful procedure with its Mia device designed for percutaneous mitral and tricuspid repairs. The Newtown, Penn.-based company’s MIA...
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Blood test could accurately diagnose heart disease
[Image by Nephron – Own work, CC BY-SA 3.0]A simple blood test could accurately diagnose heart disease in 2 hours, according to new data published by life science company Prevencio. Prevencio...
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Study: Patient error cuts dose in half for inhalers
Researchers from Rice University and Baylor College of Medicine have identified patient errors that cause inhaler users to get about half as much medicine as they should from each dose. The team said...
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Amend Surgical wins FDA nod for NanoFuse BA bone graft extender
Amend Surgical said today that it won 510(k) clearance from the FDA to market its NanoFuse BA as a bone graft extender for spine and orthopedic indications. The Alachua, Florida-based company’s...
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Tandem claims 1st remote software update for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) said today that it released a software update using the company’s Tandem Device Updater tool for its t:slim insulin pumps purchased before April 2015. It marks the 1st...
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Study: Insurers paid double for hip and knee implants
Health insurers essentially paid double the price for hip and knee implants over a 5-year period, according to a study published this week in the Journal of the American Medical Assn. Researchers at...
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Tie forces 2nd Senate Finance vote on CMS nominee Verma
A tie vote yesterday by the U.S. Senate’s Finance Committee on Seema Verma, the nominee to head the Centers for Medicare & Medicaid Services, reportedly prompted the panel to schedule another...
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Glenmark, Evestra ink deal to develop generic NuvaRing
Glenmark Pharmaceuticals and Evestra said today that the companies inked a development, license and commercialization deal for a generic version of Merck’s NuvaRing. Development of the...
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Analyst bearish on intermediate-risk TAVR uptake, but still sees market as...
While transcatheter aortic valve replacement technologies are on target to becoming a $5 billion market by 2021, analysts believe the path to indications for intermediate risk patients may be slower...
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