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Biotronik’s Eluna 8 MRI-safe pacer hits the market in Japan
Biotronik yesterday said that its Eluna 8 MRI-safe pacemaker hit the market in Japan, for 1.5-tesla full-body scans and conditional 3T scans. “Heart disease is the 2nd-most prominent cause of mortality...
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InVivo looks to blaze ‘Bioengineered Neural Trails’ in spinal cord injury...
InVivo Therapeutics (NSDQ:NVIV) said today it is looking to ‘Bioengineered Neural Trails’, injectable biomaterial and neural stem mixtures, to help treat chronic spinal cord injuries. The Cambridge,...
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FDA: Class II recall for 3 Philips Allura Xper vascular x-ray systems
The FDA yesterday published a Class II recall notice for a select number of Royal Philips (NYSE:PHG) Integris Allura Xper vascular system, designed for vascular x-ray imaging applications over issues...
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MassDevice.com +3 | The top 3 medtech stories for December 1, 2015
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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ClearCorrect continues legal brawl with Align, files for inter partes
ClearCorrect is continuing its fight with Align Technology (NSDQ:ALGN) over clear orthodontic liners, saying today it filed an Inter Partes Review with the United States Patent and Trademark Office....
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Drug pricing scandal: Pharma’s loss is medtech’s gain
The scandal swirling round drug pricing is pushing investors to medical device stocks in lieu of pharmaceutical and biotech plays. Edwards Lifesciences (NYSE:EW), Boston Scientific (NYSE:BSX) and...
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Toshiba and Ziehm to offer C-arms in partnership deal
Toshiba (TYO:6502) said today it will offer mobile C-arms commercially available through a partnership with Ziehm Imaging. Through the newly inked partnership, Toshiba will offer both fixed C-arm...
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ALung’s artificial lung tech selected for landmark pivotal trial
ALung Technologies said today its Hemolung RAS extracorporeal carbon dioxide removal device has been selected for use in the world’s 1st pivotal trial of ECCO2R technology used to treat patients with...
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Chinese government agrees to easier medical device market access for foreign...
By Stewart Eisenhart, Emergo Group The US and Chinese governments have agreed to several measures that would provide faster and more transparent market access in China for foreign medical device...
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Medtronic’s Q2 earnings beat estimates
Medtronic‘s (NYSE:MDT) fiscal 2nd-quarter earnings beat expectations as revenues met estimates, prompting the medical device leviathan to raise the low end of its profit forecast. Fridley, Minn.-based...
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FDA lifts final warning letters for AngioDynamics
AngioDynamics (NSDQ:ANGO) said today that the FDA closed out a pair of warning letters sent in 2011 and 2014, closing the book on all warning letters sent to the Latham, N.Y.-based medical device...
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Mitralign launches feasibility trial for Trialign tricuspid valve repair
Mitralign said today that it enrolled the 1st patient in the Scout feasibility trial of its Trialign tricuspid valve repair device under an investigational device exemption. The Tewksbury, Mass.-based...
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Report: TMVR at least 4 years from U.S. market
Transcatheter mitral valve replacements are at least 4 years out from hitting the U.S. market, despite the $2 billion recently dropped on companies developing the technology by some of the top names in...
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Boston Scientific leads $40m round for NxThera
NxThera said today that Boston Scientific (NYSE:BSX) led a $40 million funding round for its Rezūm device, saying it plans to boost its sales footprint in the U.S. and Europe. Existing backers Aberdare...
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FDA: InVivo spinal scaffold trial cleared from pilot to pivotal
InVivo Therapeutics (NSDQ:NVIV) said today it won conditional approval to convert its ongoing Neuro-Spinal scaffold pilot study to a pivotal probable benefit study, allowing the company a faster path...
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Surefire Medical raises $15m in Series C
Direct-to-tumor delivery system developer Surefire Medical said yesterday it brought in $15 million in a Series C round to support the global launch of its Surefire Precision device designed to treat...
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Defect claims beat preemption in Ethicon pelvic mesh cases
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon must face design defect claims in 37 of the 23,000 lawsuits filed against it over its pelvic mesh products, a federal judge in West Virginia ruled...
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Fed. Circ. upholds Hill-Rom patent’s invalidity
The United States Court of Appeals for the Federal Circuit today upheld a previous ruling by the Patent Trial and Appeal Board which found Hill-Rom Holdings (NYSE:HRC) patent for hospital bed...
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MassDevice.com +3 | The top 3 medtech stories for December 3, 2015
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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BC Technical acquires MRI/CT parts & service company Magnaserv
BC Technical said yesterday it acquired MRI and CT focused independent service organization MagnaServ. West Jordan, Utah-based BC Technical is the U.S.’s largest non-OEM medical imaging parts...
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