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FDA approves Vasorum’s Celt ACD vascular closure device
Vasorum said today that it won pre-market approval from the FDA for its Celt ACD vascular closure device. The Dublin-based company said the Celt ACD is designed to close punctures to the femoral artery...
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Medtronic recalls pacing leads on design standards snafu
Updated to include comment from Medtronic Medtronic (NYSE:MDT) last month recalled 1 of its temporary pacing leads due to a design standards snafu. In a June 16 letter to customers who bought the...
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Johnson & Johnson gets in on 3D printing with Materialise deal for titanium...
Johnson & Johnson (NYSE:JNJ) said this week that it inked a deal with 3D printing shop Materialise for titanium craniofacial implants customized to individual patients’ anatomies. Leuven,...
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Hologic inks marketing deal with Bovie Medical for J-Plasma surgical tool
Bovie Medical (NYSE:BVX) said today it inked a sales channel partnership deal with Hologic, (NSDQ:HOLX) adding Bovie’s J-Plasma product line to its portfolio. The deal, which goes into effect...
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FlexDex Surgical closes $5m Series B, preps launch of laparoscopic tools
FlexDex Surgical said today that it raised a $5 million Series B round it plans to use to advance the laparoscopic surgery tools it’s developing. Get the whole story at our sister site, Medical Design...
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LifeBond wins FDA IDE clearance for LifeSeal sealant kit
LifeBond said today it won an Investigational Device Exemption from the FDA to initiate a clinical study of its LifeSeal surgical sealant kit. The company’s LifeSeal kit includes a specific...
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InfoBionics, BioTelemetry each claim win in patent spat
Both BioTelemetry (NSDQ:BEAT) and digital health startup InfoBionic celebrated victory in their patent fight with each other over wireless cardiac monitoring technology. But the battle is far from...
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Tandem Diabetes to integrate TypeZero’s artificial pancreas tech
Tandem Diabetes Care (NSDQ:TNDM) said today it inked a license agreement with TypeZero Technologies to integrate TypeZero’s artificial pancreas into Tandem’s next-gen t:slim insulin pump. TypeZero’s...
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Sunshine Heart raises $3.5m
Sunshine Heart (NSDQ:SSH) said today it raised $3.5 million in a direct offering to a single investor through the sale of convertible preferred stock. The Eden Prairie, Minn.-based company said it...
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MassDevice.com +5 | The top 5 medtech stories for July 21, 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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Philips connects Trilogy ventilators to the Internet of Things
Royal Philips (NYSE:PHG) said today its Trilogy family of portable ventilators will be connected to its Care Orchestrator connected care management application. Get the rest of the story at our sister...
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Stryker translates CMS claims data for hospitals
Stryker (NYSE:SYK) said today its Stryker Performance Solutions business unit is now offering a new Episode Performance Manager tool designed to CMS data into actionable data for hospitals. The newly...
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Halyard Health, Belintra ink sterile packaging & logistics pact
Medical technology company Halyard Health (NYSE:HYH) and Belintra, a healthcare logistics provider, will pursue a co-marketing partnership focused on improving the sterility of wrap products before...
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Relievant Medsystems wins FDA clearance for Intracept ablation device for low...
Relievant Medsystems said today it won FDA 510(k) clearance for its Intracept intraosseous nerve ablation system designed for the treatment of chronic lower back pain. The company touted the system as...
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FDA panel votes in favor of Dexcom G5 dosage label expansion
UPDATED July 22, 2016, with comment from Dexcom. An advisory panel recommended today that the FDA grant Dexcom‘s (NSDQ:DXCM) bid for a non-adjuctive dosing claim for its G5 continuous glucose monitor...
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US FDA urges national device evaluation system incorporating UDI
By Stewart Eisenhart, Emergo Group Top US Food and Drug Administration officials are pushing for implementation of a national system for evaluating medical device pre- and post-market data including...
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Stryker’s Q2 numbers top estimates, outlook raised on 2016 sales and earnings
Stryker (NYSE:SYK) shares ticked down in pre-market trading today despite a 2nd consecutive “beat & raise” quarter that saw the medical device giant top both sales and earnings forecasts and boost...
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Profits, sales up during Q2 for GE Healthcare
Profits and sales grew during the 2nd quarter for GE Healthcare (NYSE:GE), helping the industrial conglomerate beat Wall Street’s earnings forecast. GE Healthcare’s operating profits rose 11% to $782...
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Plaintiff’s $8m win in DePuy ASR hip trial survives Johnson & Johnson’s appeal
An $8 million plaintiff’s award in a product liability lawsuit brought over the DePuy ASR XL metal-on-metal hip implant made by Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics survived...
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India’s proposed stent pricing cap said to squash new product introductions
India’s move toward capping the price on coronary stents reportedly has medical device makers rethinking their strategies there and even shelving new product rollouts. “With price controls, margins of...
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