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Stryker’s Concentric Medical wins Class II FDA label for Trevo clot retrieval...
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II. Concentric Medical submitted a request for...
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Align Technology pays $44 million for new Santa Clara property
Align Technology (NSDQ:ALGN) said last week it paid $44 million to pick up new properties in Santa Clara, Calif. The company said it already delivered $1 million in an escrow payment, but has not yet...
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Nephros wins 510(k) for HydraGuard bacterial water filter
Nephros (OTC:NEPH) said today it won FDA 510(k) clearance for its HydraGuard 10″ UltraFilter designed for water bacterial filtration. The River Edge, N.J.-based company said its HydraGuard 10″...
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MiMedx enters legal spat with 2 former sales reps
MiMedx (NSDQ:MDXG) this month released information on lawsuits filed against and by the company involving 2 former sales reps. The Marietta, Ga.-based company said it terminated the employees after...
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Sight Sciences wins Health Canada nod for TRAB 360
Venture-backed ophthalmic medical device company Sight Sciences said last week it won Health Canada approval for its TRAB 360 trabeculotomy system. The TRAB 360 system is now cleared for the...
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MassDevice.com +5 | The top 5 medtech stories for December 27, 2016
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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Precision Spine wins FDA 510(k) for AccuFit lateral plate system
Precision Spine said today it won FDA 510(k) clearance for its AccuFit lateral plating system designed to treat spinal instability. The Parsippany, N.J.-based company’s AccuFit lateral plate system...
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Abbott wins US antitrust approval for $25B St. Jude buy
The US Federal Trade Commission today granted approval to Abbott (NYSE:ABT) to complete its proposed $25 billion acquisition of St. Jude Medical (NYSE:STJ). The approval came with a caveat that the...
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Endologix puts hold on AFX shipments over manufacturing issues
Endologix (NSDQ:ELGX) said today it is temporarily holding shipments of its AFX Endovascular abdominal aortic aneurysm system as it completes an investigation of manufacturing issues with the devices....
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Neovasc granted stay as it appeals $70m CardiAQ loss
Neovasc (NSDQ:NVCN) said today it won a stay of judgement as it looks to appeal a $70 million loss to mitral valve rival and Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve. The stay from the...
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Z-Medica inks 3-year $3m QuickClot supply deal with NYPD
Hemostatic device developer Z-Medica said today it inked a 3 year, $2.7 million deal to supply the New York City Police department with QuickClot belt trauma kits. The QuickClot belt trauma kit...
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Managing medical device cybersecurity in the postmarket: At the crossroads of...
By: Suzanne B. Schwartz, M.D., M.B.A. Protecting medical devices from ever-shifting cybersecurity threats requires an all-out, lifecycle approach that begins with early product development and extends...
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Biogen, Ionis win FDA approval for first spinal muscular atrophy drug
Biogen (NSDQ:BIIB) said last week that it won FDA approval for its spinal muscular atrophy treatment, Spinraza. The drug is the 1st treatment approved in the U.S. for spinal muscular atrophy, a...
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Sanofi sues Nordisk over Tresiba marketing claims in U.S.
Sanofi (NYSE:SNY) said yesterday that it is suing competitor Novo Nordisk (NYSE:NVO) for “misleading” marketing materials that claim Sanofi’s insulin drugs Lantus and Toujeo will be “blocked” by U.S....
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MiMedx touts Aetna reimbursement win for EpiFix implant
MiMedx (NSDQ:MDXG) said today that it won coverage from Aetna Inc. for its EpiFix allograft effective December 23rd. The insurance company classified EpiFix as “medically necessary” for the treatment...
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NanoVibronix lands Health Canada nod for patch-based wound healing device
NanoVibronix (NSDQ:NVBXU) said today that it won approval from Health Canada to sell its WoundShield device in Canada. The Elmsford, N.Y.-based company has also won CE mark approval for the device in...
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IntelGenx, Endo Ventures ink development and commercialization deal
IntelGenx (OTCQX:IGXT) said today that it inked a development and commercialization deal with pharmaceutical company Endo Ventures. According to the agreement, the 2 companies will develop a new...
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OneMedNet, Vida Diagnostics partner to develop image sharing for pulmonologists
OneMedNet Corp. said today that it landed a collaboration deal with Vida Diagnostics Inc., to develop an image exchange and data sharing solution for diagnostic and therapeutic procedural workflows for...
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Researchers develop nanodiscs to deliver personalized cancer therapy
Researchers from the University of Michigan have developed nanodiscs that deliver a customized therapeutic vaccine to treat colon and melanoma cancer in mice. The team’s work was published in Nature...
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MassDevice.com +5 | The top 5 medtech stories for December 28, 2016
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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