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Senseonics submits FDA PMA application for Eversense CGM
Senseonics (NYSE:SENS) said today it submitted a premarket approval application to the FDA for its Eversense continuous glucose monitoring system. The Eversense system includes an implanted glucose...
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From Zero to Six Million – Using a Component Management Process to Scale Up...
Drug delivery devices constitute one of the most rapidly growing segments of the medical device manufacturing market. Makers focus substantial R&D efforts on designing delivery mechanisms for new...
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Anika’s pipeline & clinical data create steady growth in Q3
Shares in Anika Therapeutics (NSDQ:ANIK) rose yesterday after the company met expectations on Wall Street with its 3rd-quarter results. The Bedford, Mass.-based company posted profits of $8.9 million,...
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OCTANe launches business growth services
Aliso Viejo, Calif.-based medtech business accelerator OCTANe said yesterday it launched OCTANe Growth Services, a new business accelerator program that aims to aid its members and partners in growing...
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FDA OKs stem cell, gene therapy trial for ALS
The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural...
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Novo Nordisk shares dive after long-term growth cut
(Reuters) — Top insulin maker Novo Nordisk (NYSE:NVO) slashed its long-term profit growth forecast today, signaling no let-up in its struggles to crack the U.S. market to which its chief executive...
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St. Jude calls global stop to Nanostim implants over battery issues
St. Jude Medical (NYSE:STJ) said today it is pausing the implantation of its Nanostim leadless pacemaker due to reports of battery related problems with electronic data reporting. The Little Canada,...
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St. Jude wins FDA nod for Amplatzer PFO occluder
St. Jude Medical (NYSE:STJ) today won FDA approval for its Amplatzer patent foramen ovale occluder device, designed to reduce the risk of stroke in patients who’ve experienced a PFO-related stroke....
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MassDevice.com +5 | The top 5 medtech stories for October 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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AliveCor adds weight, activity monitoring to Kardia app
AliveCor today said that its Kardia Mobile health monitoring app will now integrate weight and physical activity readings, lifting the number of vital stats the application monitors to 5. The...
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Skyline Medical pulls trigger on 1-for-25 reverse split
Skyline Medical said its board of directors approved and the company initiated a reverse stock split, effective at the close of business yesterday. The move put 1 share of Minneapolis, Minn.-based...
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Hospitals may face bigger penalties for readmissions than deaths
(Reuters) – Medicare penalties are tied to fewer repeat hospitalizations for some common health problems, but a new study suggests current policy doesn’t encourage hospitals in the United States to...
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Cardinal Health inks 4 new distro agreements
Cardinal Health (NYSE:CAH) today announced 4 new strategic distribution agreements, looking to expand its product portfolio with new coronary stents and percutaneous transluminal coronary angioplasty...
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FDA posts another Class I HeartWare HVAD recall
The FDA today posted a Class I recall notice for select Medtronic (NYSE:MDT) HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from...
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Chinese regulators set early 2017 launch date for medical device priority...
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: The China FDA’s final rule on its priority review program for medical devices will come into force in January 2017. The program is open...
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ReWalk Robotics raises $12m, forecasts Q3 sales beat
ReWalk Robotics (NSDQ:RWLK) last week priced a stock-and-warrants offering worth more than $12 million and said it expects its 3rd-quarter earnings to beat expectations on Wall Street. Yokneam, Israel-...
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Guidance cut, Q3 sales miss push Zimmer Biomet shares down
Zimmer Biomet (NYSE:ZBH) shares fell sharply this morning after the orthopedics giant posted lower-that-expected 3rd-quarter sales and cut its guidance for the rest of the year. Warsaw, Ind.-based...
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TCT 2016: Stents, stents, stents on Day 1
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning yesterday. We’ll update this post throughout the day as new...
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NASS 2016: Interest grows in surgical robotics for spinal procedures
Mazor Robotics (NSDQ:MZOR) unveiled its next-generation robot-assisted surgery system and Globus Medical (NYSE:GMED) for the 1st time showcased the functional prototype of its Excelsius platform at the...
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EpiPen price hike cost Pentagon millions
Mylan Pharmaceuticals‘ (NSDQ:MYL) 500% price increase on its epinephrine auto-injector cost the U.S Defense Dept. millions, according to data provided to Reuters. The Pentagon spent $57 million on...
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