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Gore wins Health Canada approval for Excluder stent graft
W.L. Gore & Associates said today it won Health Canada approval for its Excluder iliac branch endoprosthesis designed for the endovascular treatment of common iliac artery aneurysms or aortoiliac...
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US gov’t delays CMS hospital rating system
The Obama Administration is holding off from publishing new hospital-quality ratings over concerns raised by healthcare providers and Congress over the methodology of the ratings system, the Wall...
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FujiFilm wins 510(k) for Vevo MD clinical ultrasound system
Fujifilm Sonosite (TSE:4901) subsidiary VisualSonics said today it won FDA 510(k) clearance for its Vevo MD ultra high frequency clinical ultrasound system, the company’s 1st offering in the clinical...
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Medtronic launches Barrx 360 radiofrequncy ablation cath in US
Medtronic (NYSE:MDT) said today it launched its Barrx 360 Express radiofrequency ablation balloon catheter designed to treat Barrett’s esophagus. The Barrx 360 Express is a self-adjusting...
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Surgical bot maker Medtech Surgical sells 10 ROSA units, looks to shift...
French surgical robotics firm Medtech Innovative Surgical Technology said this month it sold 10 ROSA robotic surgical systems during its fiscal 3rd quarter of 2016, with 7 going to the U.S., 2 in China...
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MassDevice.com +5 | The top 5 medtech stories for April 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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US FDA centralizes effort to address combination product issues
By Stewart Eisenhart, Emergo Group US medical device and pharmaceutical regulators are launching a new committee to more comprehensively address policy and implementation challenges associated with...
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Clear Guide closes $3m Series A to support Scenergy image guidance system
Clear Guide Medical said today it closed a $3 million Series A round of financing to support its Scenergy CT-Ultrasound fusion and image guidance system designed to aid in minimally invasive biopsies...
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Si-Bone touts maintained results at 2 years in iFuse study
Si-Bone this week released 2-year results from the SIFI trial of iFuse implant system designed for sacroiliac joint fusion procedures, touting improvements in quality of life and a 28% reduction in...
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Boston Scientific wins rehearing in PTAB case against UAB
The U.S. Patent Trial and Appeal board granted a rehearing request to Boston Scientific (NYSE:BSX) for an inter partes review of a patent held by UAB Research Foundation related to treating cardiac...
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FDA mulls banning electro stim devices for treating self-injury, aggressive...
The FDA today proposed a ban on electrical stimulation devices used to treat self-injurious or aggressive behavior over concerns about the safety of the devices. ESDs are designed to deliver electrical...
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Imaging Advantage partners with MIT to create X-ray imager AI
Cloud-based radiology service company Imaging Advantage said today it launched a machine learning research initiative with faculty members from the Massachusetts Institute of Technology, Harvard...
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BD launches Genesis low-temp sterilization containers
Becton Dickinson & Co. (NYSE:BDX) said today it launched its Genesis low temperature rigid sterilization container system designed for surgical instrument sterilization. The Genesis container...
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Fresenius raises $39m
Fresenius (NYSE:FMS) has raised $39 million in a new round of equity financing, according to an SEC filing. The company said that managers of the offering may require members to contribute capital from...
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SRI International spins off wearable robotics biz Superflex
Research group SRI International said yesterday it is spinning off a wearable robotics focused biz Superflex, which aims to develop robotics to enhance the human musculoskeletal system. The technology...
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MassDevice.com +5 | The top 5 medtech stories for April 22, 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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Amniox Medical touts reimbursement wins, extended cryo lifespan
Amniox Medical this month touted a reimbursement win from Palmetto Medicare as well as a 2-year cryopreserved lifespan for its Neox Cord 1k as it attempts to position itself as a market leader in wound...
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Update: Google Glass startup Augmedix raises $17m in strategic investment round
Updated with more recent funds info from Augmedix Google Glass startup Augmedix said today it closed a $17 million strategic round of funding with investments from 5 healthcare systems across the U.S....
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FDA grants IDE to NovoCure for phase II Optune trial
NovoCure (NSDQ:NVCR) said today that Radiation Therapy Oncology Group Foundation won FDA investigational device exemption to conduct a Phase II pilot test of NovoCure’s Optune in conjunction with...
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Gore touts 1st implant of Synecor in CQI trial
W.L. Gore & Associates said today its Synecor biomaterial designed for hernia repair was used in the 1st procedure of its clinical quality improvement project. The robotically assisted surgical...
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