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Medical device companies fear parallel regulation after Brexit vote
Medical Device companies fear that Britain’s exit from the European Union could result in a “parallel” regulatory system which would require them to file separate applications to access the U.K. and...
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FDA approves Concordia’s Photofrin 630 laser
Concordia International (NSDQ:CXRX) said it won pre-market approval from the FDA for its Photofrin 630 laser, which is designed to activate an anti-cancer drug in patients with throat and lung cancers....
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Study: Initially CE Marked medical devices have higher recall rate
U.S. medical devices which won CE Mark approval in the European Union prior to gaining FDA clearance have a nearly 3 times higher rate of safety alerts and recalls, according to a new study published...
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Appeals court upholds patent win for Medtronic’s Cardiocom
A federal appeals court yesterday upheld a win for Medtronic (NYSE:MDT) subsidiary Cardiocom in a patent battle with Robert Bosch Healthcare Systems. The U.S. Court of Appeals for the Federal Circuit...
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Leading the battle against sepsis: A MassDevice podcast with Spectral Medical...
Spectral Medical CEO Dr. Paul Walker has been focused on finding a solution to identify and treat sepsis, and specifically endotoxins that are known to trigger it, for over 20 years. Sepsis affects...
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JustRight Surgical wins FDA 510(k) for 3mm pediatric vessel sealing system
JustRight Surgical said today it won FDA 510(k) clearance for its JustRight 3mm pediatric surgery vessel sealing system. The Boulder, Colo.-based company touted the win as the 1st and only from the FDA...
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MassDevice.com +5 | The top 5 medtech stories for June 30, 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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SRS Medical wins CE Mark for Spanner prostate stent
SRS Medical Systems said yesterday it won CE Mark approval in the European Union for its Spanner temporary prostatic stent designed to be used as both an indwelling Foley catheter and an intermittent...
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Luminex closes Nanosphere buy
Luminex (NSDQ:LMNX) said today that it closed its buy of Nanosphere (NSDQ:NSPH) through the purchase of 45.3 million shares at $1.70 per share, offering up $76.9 million for the company. The company...
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NuVasive ponies up $45m to settle Medtronic beef
NuVasive Inc. (NSDQ:NUVA) said yesterday that it agreed to pay Medtronic (NYSE:MDT) $45 million to settle their long-running patent infringement beef. The companies expect to reach a final agreement...
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Be a champion for clinical trial diversity
By: Jonca Bull, M.D. The FDA is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions. The first part of the campaign will be launched on June 19,...
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Bioventus files for $150m IPO
Orthobiologics maker Bioventus yesterday registered for an initial public offering it plans to use to pay off debt. Durham, N.C.-based Bioventus was formed in 2012 when Smith & Nephew (NYSE:SNN)...
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Sunshine Act: Medical device and drug companies paid docs $7.5B last year
(Reuters) — Doctors and hospitals in the U.S. received $7.52 billion in payments and ownership and investment interests from the makers of drugs and medical devices in 2015, according to data released...
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Spirometrix lands $17m Series C for breath-based diagnostic device
Spirometrix said yesterday that it raised $17.4 million in the 1st tranche of its Series C round for the breath-based diagnostic device it’s developing for asthma patients. Shanghai Fosun...
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Biotronik wins CE Mark for Edora MRI-adaptable pacers
Biotronik said today that it won CE Mark approval in the European Union for its Edora line of MRI-adaptable pacers. The German medical device company said the Edora pacemakers and cardiac...
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Nestle poaches Fresenius CEO Schneider | Personnel Moves for July 1, 2016
Nestle poaches Fresenius CEO Schneider Nestle (VTX:NESN) lured the CEO of Fresenius (NYSE:FMS), Ulf Mark Schneider, to the corner office this week. Fresenius promoted CFO Stephan Sturm to replace...
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InspireMD prices $15m offering
InspireMD (OTC:NSPR) this week priced a new public offering, looking to bring in approximately $15 million through the sale of 442,424 shares of Series B convertible preferred stock and accompanying...
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IntriCon slips on missed Q2 prelims
IntriCon (NSDQ:IIN) saw shares fall over 9% after releasing preliminary 2nd quarter earnings that are off the mark, well under Street analysts expectations. The Arden Hills, Minn.-based company said it...
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Bovie inks J-Plasma distribution deal with Arteriocyte
Bovie Medical (NYSE:BVX) said this week it inked a sales channel partnership agreement with Arteriocyte Medical Systems to sell Bovie’s J-Plasma to its network of plastic surgeons. Through the deal,...
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Lombard touts 1st commercial use of IntelliFlex LP with Aorfix stent graft
Lombard Medical Technologies (NSDQ:EVAR) today touted the 1st commercial use of its IntelliFlex low profile delivery system designed to implant the Aorfix endovascular stent graft in a procedure to...
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