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AHA: Wearable defib may be alternative to ICD for select patients
Wearable automatic defibrillators may be a viable alternative to implantable cardioverter-defibrillators in patients at risk for life threatening heart rhythm abnormalities, according to the American...
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Addressing issues relating to combination products: Human factors
By: Jill Hartzler Warner, J.D., and Thinh Nguyen Combination products represent an important and growing category of therapeutic and diagnostic products under the FDA’s regulatory authority. These...
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Tegra Medical receives Manufacturing Excellence Award from Worcester Business...
Tegra Medical is proud to announce that it has received the Manufacturing Excellence Award from the Worcester Business Journal. The eight recipients of this inaugural award were announced in its March...
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FDA clears Corindus Vascular Robotics CorPath for peripheral interventions
Corindus Vascular Robotics (NYSE:CVRS) said today that it won FDA 510(k) clearance for its robotic-assisted CorPath system for peripheral interventions, a year after launching a clinical trial. The...
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Colibri Heart Valve looks to raise $25m Series C for TAVR device
Colibri Heart Valve is looking to raise a $25 million Series C for the ready-to-use replacement heart valve it’s developing and has already put $1.25 million into its coffers. Broomfield, Colo.-based...
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Report: U.S. IPOs hit 7-year low during 2016 1st quarter
The U.S. market for initial public offerings hit its lowest mark during the 1st quarter since the financial crisis hit in 2008 and 2009 and every flotation was for a healthcare company, according to a...
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St. Jude wins CE Mark for expanded suite of cardiac leads
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union and launched 3 new Quartet left ventricular leads. The newly released leads are designed for more effective...
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Organ-on-chip dev Emulate raises $29m
Boston-based biotech developer Emulate Inc. said yesterday it raised $28.7 million in a Series B round of financing looking to boost its organ-on-chip technology, and looks to bring in another $16.3...
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MGH launches study with Philips’ IntelliSite digital pathology
Royal Philips (NYSE:PHG) said today that Massachusetts General Hospital will operate as the key testing site for a precision study of its Intellisite Solution digital pathology whole slide imaging. The...
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The exodus of key personnel at Google’s Verily | Personnel Moves for March...
There’s reportedly a rare exodus under way of key personnel from a Google (NSDQ:GOOG) operation, its Verily healthcare “moonshot,” with former employees blaming the mercurial leadership of CEO Andrew...
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Tenex Health wins 510(k) for TX2 MicroTip
Tenex Health said today it won FDA 510(k) clearance for its TX2 MicroTip designed to treat tendinosis of the shoulder and hip. The Lake Forest, Calif.-based company said that the new TX2 MicroTip is 2...
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MassDevice.com +5 | The top 5 medtech stories for March 29, 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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FDA: Don’t use OxySure’s portable oxygen generator
The FDA today released a safety letter warning against the use of OxySure Therapeutic’s Portable Emergency Oxygen System model 615. The safety communication comes based on complaints of adverse events...
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New Jersey appeals court upholds $11m pelvic mesh decision against J&J
A New Jersey appeals court today upheld a $11.1 million jury award against Johnson & Johnson’s (NYSE:JNJ) Ethicon subsidiary in a case concerning injuries caused by the company’s Prolift vaginal...
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MedStar shuts down network on virus concerns
(Reuters) – MedStar Health’s computer systems remained offline on Tuesday for the second straight day as the non-profit, one of the biggest medical service providers in the U.S. capital region, worked...
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EMED seeks injunction against ReproMed
EMED Technologies said today that it is seeking a federal court injunction against competitor Repro-Med Systems to keep the company from selling home infusion pumps and needles for subcutaneous...
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Trinity Medical picks up CasMed’s neonate disposables for $3m
Trinity Medical Devices said yesterday that it paid $3.35 million for CAS Medical System‘s (NSDQ:CASM) line of neonatal intensive care disposables. The deal includes a an additional $400,000 milestone...
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US FDA expands UDI training resources for medical device companies
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published five new training and education modules on the online platform for the agency’s Unique Device Identification (UDI)...
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Retina Implant wins CE Mark for next-gen blindness implant
Retina Implant said today that it won CE Mark approval in the European Union for the latest iteration of its subretinal implant for patients blinded by retinitis pigmentosa. The Alpha AMS is the...
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Ex-AMO CEO Mazzo wants stay in insider trading case pending Supreme Court...
James Mazzo, the former Advanced Medical Optics CEO who was indicted 2 years ago, wants a federal judge to agree to a stay pending a U.S. Supreme Court decision this fall over issues he claims could...
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