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FDA warns device makers over unapproved claims
U.S. FDA recently released 2 warning letters to companies that it claims are marketing products for unapproved medical uses. London-based Medical Specialties of California UK has sold its Penguin Cold...
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Bob Langer on drug delivery
Photo credit: Chemical Heritage Foundation Robert Langer, a pioneer in drug delivery and the most cited engineer in history, has co-founded 30 companies and treated more than 20 million patients as a...
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Abbott wins FDA nod for whole-blood molecular test for Zika
Abbott (NYSE:ABT) said today that the FDA approved its RealTime ZIKA test to detect Zika virus in whole blood for emergency use. This is the 1st molecular test made by a commercial manufacturer that...
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Surmodics raises guidance, beats Q1 earnings
Shares in Surmodics (NSDQ:SRDX) rose today after the medical device maker met expectations on Wall Street with its fiscal 2017 1st quarter results. The Eden Prairie, Minn.-based company posted profits...
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How to go from idea to commercialization: Interview with Dr. Marie Johnson,...
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! More...
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Nordisk tumbles on lowered outlook
Shares in Novo Nordisk (NYSE:NVO) fell -9% this morning after the pharmaceutical company missed expectations on Wall Street with its 4th quarter results and lowered its outlook for 2017. The Danish...
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Bovie Medical tanks after failing to renew J-Plasma deal with Hologic
Bovie Medical (NYSE:BVX) saw shares plummet this week after it announced it did not extend the sales channel partnership with Hologic (NSDQ:HOLX) for its J-Plasma product, which is set to expire at the...
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Johnson & Johnson medical device chief Pruden to step down
Gary Pruden, the chairman of Johnson & Johnson‘s (NYSE:JNJ) medical devices unit, is slated to step down June 1, the healthcare giant said today. Pruden, who’s worked at J&J for 32 years, is...
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Edwards pauses CardiAQ Valve clinical trial enrollment
Edwards Lifesciences (NYSE:EW) said this week it paused enrollment in the clinical trial of its CardiAQ transcatheter mitral valve implant while it performs design validation testing on the device. The...
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MassDevice.com +5 | The top 5 medtech stories for February 2, 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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QT Vascular inks Chocolate PTA distro deal with Medtronic
QT Vascular said today it inked a definitive agreement with Medtronic (NYSE:MDT) to distribute QT’s Chocolate PTA catheter for 5-years. The deal between Singapore-based QT Vascular and Fridley,...
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VisCardia closes $13m Series B, picks up Inovise Medical assets & tech
Novel heart failure device developer VisCardia said yesterday it closed a $12.5 Series B financing round and picked up the Inovise Medical’s assets and technology rights. Technology and assets from...
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PAVmed raises $1.5m in private placement
PAVmed Inc. (NSDQ:PAVMU) said today it raised $1.5 million through a private placement of Series A convertible preferred stock and Series A warrants, with funds slated to support FDA clearance of its...
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Sirtex Medical shares sink on shareholder suit
Sirtex Medical (ASX:SRX) shares fell this week after announcing it is facing a suit from shareholders alleging it breached continuous disclosure obligations and engaged in misleading and deceptive...
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Align files U.K. patent suit against ClearCorrect
Align Technology (NSDQ:ALGN) said yesterday it filed a patent infringement suit against ClearCorrect and Your Smile Direct in the UK, claiming the companies infringe patents related to its transparent...
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Second Sight wins German reimbursement for Argus II retinal prosthesis
Second Sight Medical (NSDQ:EYES) said today it won reimbursement coverage for its Argus II epiretinal prosthesis from the German Institute for the Hospital Renumeration System, covering 15 hospitals in...
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Elekta wins FDA 510(k) clearance for Venezia gynecological brachytherapy...
Elekta (STO:EKTA B) said today it won FDA 510(k) clearance for its Venezia applicator for gynecological brachytherapy, now cleared for the treatment of advanced-stage cervical cancer. The company’s...
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Lantheus wins FDA nod for Definity imaging agent label update
Lantheus Medical Imaging (NSDQ:LNTH) said today it won FDA approval for a label update on its Definity imaging agent which removed a contraindication related to use in patients with a known or...
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Braeburn pulls the plug on $150m IPO, citing market conditions
Braeburn Pharmaceuticals pulled its plans for a $150 million initial public offering yesterday, citing unstable market conditions. The Princeton, N.J.-based company 1st announced plans to go public in...
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ConMed slides on Q4 earnings miss
ConMed (NSDQ:CNMD) shares are off some 6% this week after the medical device company missed expectations with its 4th-quarter earnings. Utica, N.Y.-based ConMed posted a -14.6% profit decline to $6.7...
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