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Rotation Medical touts regenerative rotator cuff repair data
Rotation Medical today released results from a study of its regenerative rotator cuff system, touting significant new tissue formation and no tear progression in patients at 24 months. The Plymouth,...
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Apple issues more explicit guidelines for mobile medical and health app...
By Stewart Eisenhart, Emergo Group Apple has published updated guidelines for how the company reviews applications submitted for sale via its App Store, with an expanded section focused on safety...
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Vivasure lands $18m Series C
Ireland-based Vivasure Medical said today it raised $18.3 million (EU €16.2 million) in a Series C round of financing, with funding slated to support the European commercialization of its PerQseal...
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Legal eagles: St. Jude Medical faces uphill battle in lawsuit against...
Legal experts say a defamation lawsuit filed by St. Jude Medical (NYSE:STJ) against a short seller faces an uphill battle. Little Canada, Minn.-based St. Jude yesterday sued short-selling firm Muddy...
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Boston Scientific puts $25m into venous stent maker Veniti
Veniti said today that Boston Scientific (NYSE:BSX) put up $25 million for its Series D round, which it plans to use to back a clinical trial of its Vici venous stent. Veniti’s 200-patient, 60-month...
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Senate panel to investigate Mylan’s EpiPen pricing
The U.S. Senate’s investigations panel is reportedly launching a “preliminary inquiry” into Mylan’s (NSDQ:MYL) pricing of the EpiPen epinephrine auto-injector. Mylan came under fire in recent weeks for...
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Varian Medical buys Polish distributor
Varian Medical (NYSE:VAR) said yesterday that it acquired Polish distributor Candela for an undisclosed amount. Warsaw-based Candela, which employs 40 workers, was Varian’s distributor in Poland for 20...
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Neuravi wins CE Mark for EmboTrap II stent retriever
Neuravi said today it won CE Mark approval in the European Union for its EmboTrap II stent retriever and revascularization device. The device is a next-gen version of the company’s EmboTrap, and is...
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410 Medical Innovations raises $2m for LifeFlow rapid infuser
410 Medical Innovations said in a regulatory filing today that it raised a funding round worth $2.2 million. Durham, N.C.-based 410 Medical developed the LifeFlow rapid infuser for critically ill...
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AliveCor partners with Omron to integrate BP data into Kardia mobile app
AliveCor said today it is partnering with Omron Healthcare to integrate data from its Bluetooth-enabled home blood pressure devices into AliveCor’s ECG Kardia mobile application. The Mountain View,...
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biom’up announced enrollment of first patient in clinical investigation of...
biom’up announced the enrollment of the first patient in their prospective, randomized, controlled, multicenter, pivotal, clinical investigation evaluating the safety and efficacy of HEMOBLAST™ Bellows...
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FDA clears Additive Orthopaedics’ 3D-printed osteotomy wedge
Early-stage orthopedics company Additive Orthopaedics said today it won FDA 510(k) clearance for its 3D printed osteotomy wedge system. The newly cleared device from the Little Silver, N.J.-based...
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Abbott, Alere to mediate merger dispute
Alere (NYSE:ALR) told a Delaware state court yesterday that it and Abbott (NYSE:ABT) will seek to mediate their dispute over a pending, $5.8 billion merger. The dispute concerns Abbott’s role in...
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Carestream wins FDA clearance for extremities CT scanner
Carestream Health said today it won FDA 510(k) clearance for its OnSight 3D extremity system. The Rochester, N.Y.-based company’s newly cleared device uses cone beam CT tech to capture weight-bearing...
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JDRF backs Sernova’s implant for T1D
Canadian-based drug device maker Sernova Inc. is working with the Juvenile Diabetes Research Foundation on a clinical trial of Sernova’s cell pouch system to treat hypoglycemia unawareness patients...
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More Respimat data from Boehringer
Boehringer Ingelheim on Tuesday touted results from the Phase III CanoTinA asthma trial, which showed that adding tiotropium Respimat to maintenance asthma therapy in kids ages 6-11 significantly...
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Takeda looks to wearables for IBD patients
Takeda Pharmaceuticals (TYO:4502) yesterday launched a wearable watch pilot program to help people suffering with inflammatory bowel disease track their symptoms. Takeda said they will roll out the...
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MassDevice.com +5 | The top 5 medtech stories for September 8, 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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Monteris Medical wins FDA IDE nod for another Neurablate brain cancer trial
Monteris Medical said today it won FDA investigational device exemption to explore the use of its NeuroBlate system in patients newly diagnosed with glioblastoma multiforme. The NeuroBlate system is...
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Insulet lifts debt offering to $300m
Insulet (NSDQ:PODD) today released pricing for its previously announced debt offering, increasing the principal amount from $250 million to $300 million. Billerica, Mass.-based Insulet, which makes the...
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