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Biomaterial startup Regentis raises $15m
Israeli start-up Regentis Biomaterials said yesterday it raised $15 million in a Series D round of funding to support its GelrinC hydrogel-based resorbable cartilage replacement. Funds from the round...
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Portable oxygenation device maker Hemovent raises $6m
German medical device developer Hemovent said yesterday it raised $6m in a Series A round to support its portable extra corporeal membrane oxygenation system. The oxygenation system is designed to...
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Avita inks deal with EU distro deal with MSM Medical
Avita Medical (ASX:AVH) said today it inked a distribution deal with MSM Medical that will put the company in charge of selling its devices into the German, Austrian and Swiss markets. German-based MSM...
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Five things to consider when adding bluetooth to medical devices
By Michael Cassidy, Emergo Group Medical device manufacturers are increasingly adding wireless technology to their products, but how does this trend impact regulatory compliance? From cellular links to...
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NuVasive’s Q4 profits surge, swings to black for 2015
NuVasive Inc. (NSDQ:NUVA) yesterday reported 4th-quarter and full-year results that topped expectations on Wall Street, posting a Q4 profit increase of nearly 54% and swinging to black ink for 2015....
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Jury docks Johnson & Johnson $14m in pelvic mesh lawsuit
A jury in Philadelphia this week reportedly docked Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon $13.5 million in the 2nd case involving its pelvic mesh products to go to trial in a mass tort in...
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Zimmer Biomet wins 510(k) for Unite3D
Zimmer Biomet (NYSE:ZBH) said yesterday it won FDA 510(k) clearance for its Unite3D bridge fixation system designed for foot and ankle joint fusion surgery, as an alternative to traditional plates,...
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UK’s NICE backs Medtronic’s MiniMed Paradigm Veo
Medtronic (NYSE:MDT) said today the U.K.’s National Institute for Health and Care Excellence issued positive guidance recommending the MiniMed Paradigm Veo insulin pump and integrated glucose sensor...
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Titan Medical closes $7.6m offering
Titan Medical (CVE:TMD) said today it closed its most recent offering, raising $7.6 million (CAD $10.5 million) by floating 11.7 million shares at 65¢ (CAD 90¢) per share to support its Sport robotic...
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Bard touts data from Lutonix head-to-head study against MDT’s In.Pact
C.R. Bard (NYSE:BCR) subsidiary Bard Peripheral Vascular touted results showing no significant difference in a study pitting its Lutonix DCB against Medtronic‘s (NYSE:MDT) In.Pact DCB in treating...
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MassDevice.com +3 | The top 3 medtech stories for February 12, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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U.S., EU medical device associations push ‘regulatory cooperation’
Medtech industry advocacy groups on both sides of the Atlantic are pushing for regulatory cooperation in the Transatlantic Trade and Investment partnership, which is entering its 3rd year of...
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Valtech touts German reimbursement win for Cardioband
Valtech Cardio said Tuesday it won reimbursement in Germany for its Cardioband Mitral Reconstruction System designed to treat mitral regurgitation in heart failure patients. The Cardioband system is...
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RTI Surgical inks deal with Oxford Performance Materials
RTI Surgical said yesterday it inked a deal with Oxford Performance Materials to license its OsteoFab platform for spinal applications. OPM’s OsteoFab is a next-generation implant manufacturing process...
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GN Store Nord’s shares jump as profits rise in fourth quarter
(Reuters) – Shares in Denmark’s GN Store Nord jumped as much as 15% on Friday after its financial results met forecasts following previous misses, legal problems and fears over the performance of one...
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Australia’s Cochlear wants to buy govt hearing service, raises profit outlook...
(Reuters) – The Australian government said it is weighing a proposal from a consortium including hearing implant maker Cochlear Ltd. (ASX:COH) to buy a state-owned hearing service, a move likely to...
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LivaNova warns on possible endotoxin contamination in anesthesia equipment
LivaNova (NSDQ:LIVN) issued an urgent field safety notice concerning possible endotoxin contamination of unnamed surgical equipment related to anesthesia. LivaNova has not publicly released which...
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Cardica pulls the trigger on 1-10 reverse split
Cardica (NSDQ:CRDC) said it is initiating a 1-for-10 reverse split of its common stock, effective today. Company stockholders approved a series of alternate amendments to effect a reverse stock split...
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Emergo analysis: Fewer 510(k) submissions from US medical device firms in 2015
By Stewart Eisenhart, Emergo Group In 2015, fewer US-based medical device companies submitted 510(k) applications to the Food and Drug Administration than at any point in the last five years. Also last...
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Analyst doubts FDA’s estimate of fetal deaths linked to Bayer’s Essure
An analyst who examined the FDA’s adverse events website for cases involving the controversial Essure permanent contraception device made by Bayer (ETR:BAYN) said the federal safety watchdog likely...
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