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Amend Surgical wins FDA nod for NanoFuse BA bone graft extender
Amend Surgical said today that it won 510(k) clearance from the FDA to market its NanoFuse BA as a bone graft extender for spine and orthopedic indications. The Alachua, Florida-based company’s...
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Tandem claims 1st remote software update for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) said today that it released a software update using the company’s Tandem Device Updater tool for its t:slim insulin pumps purchased before April 2015. It marks the 1st...
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Study: Insurers paid double for hip and knee implants
Health insurers essentially paid double the price for hip and knee implants over a 5-year period, according to a study published this week in the Journal of the American Medical Assn. Researchers at...
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Tie forces 2nd Senate Finance vote on CMS nominee Verma
A tie vote yesterday by the U.S. Senate’s Finance Committee on Seema Verma, the nominee to head the Centers for Medicare & Medicaid Services, reportedly prompted the panel to schedule another...
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Glenmark, Evestra ink deal to develop generic NuvaRing
Glenmark Pharmaceuticals and Evestra said today that the companies inked a development, license and commercialization deal for a generic version of Merck’s NuvaRing. Development of the...
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Analyst bearish on intermediate-risk TAVR uptake, but still sees market as...
While transcatheter aortic valve replacement technologies are on target to becoming a $5 billion market by 2021, analysts believe the path to indications for intermediate risk patients may be slower...
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Cydar lands Roche exec for 3D imaging software play
Cydar EV, a medical software start-up, said this week that it hired several new directors, including Roche’s recently-retired chairman Franz Humer. The U.K.-based company is developing cloud-based...
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Medtronic: Certain stent grafts may confuse during implantation
[Image courtesy of Medtronic]Some Endurant and Endurant II bifurcated stent graft systems could fool doctors into thinking a more serious endoleak is taking place during the implant procedure, causing...
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Philips Respironics recalls select V60 ventilators over software shut down...
Royal Philips (NYSE:PHG) Respironics business is recalling a select number of its V60 respiratory ventilators with its version 2.20 software over issues with the software causing the blower motor to...
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New Requirements for Medical EMC: IEC 60601-1-2 Edition 4
Plan now to ensure your medical devices comply with new EMC requirements by the December 2018 effective date. Since the development cycle can be 2-3 years, it is important to understand the new IEC...
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EnGeneIC wins orphan drug designation for targeted nanocells
EnGeneIC said today that the FDA granted orphan drug designation to the company’s targeted EDV nanocells for the treatment of glioblastoma multiforme. The clinical stage biopharmaceutical company is...
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MassDevice.com +5 | The top 5 medtech stories for March 2, 2017
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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Saphena files counter-suit against Getinge’s Maquet
Saphena Medical said today that late last month that it, and Dr. Albert Chin, filed counterclaims against Getinge‘s (PINK:GETI B) medical subsidiary Maquet Cardiovascular in response to a suit alleging...
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Research shows stem cell treatment could improve irregular heartbeat
A study published in Stem Cells Translational Medicine showed that treating heart patients with mesenchymal stem cells does not increase their risk for irregular heart beat and instead improved the...
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Neocis wins FDA nod for 1st dental robotic guidance system
Robotic medical device developer Neocis said today it won FDA 510(k) clearance for its Yomi robotic guidance system for dental implant procedures, touting it as the 1st of its kind to win a nod from...
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Contact lens maker VTI plans IPO Down Under
Visioneering Technologies this week priced its A$33.3 million initial public offering on the Australian Securities Exchange. The U.S.-based contact lens maker said it’s offering 79.4 million shares of...
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Analysis: 5 ways Trump is making things uncertain for medtech
Want a word to sum up 2017? Try “uncertainty.” Chris Newmarker, Managing Editor [Image courtesy of the White House]Wall Street investors remain on a sugar high from the new Trump administration and...
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Keystone Heart, Venus Medtech ink Asian TAVR stroke partnership deal
Keystone Heart and Chinese heart valve maker Venus Medtech said today they inked a partnership deal covering China and other Asian markets. Through the deal, the companies will provide Venus Medtech’s...
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Margins boost helps to push ConvaTec shares to record high
(Reuters) – British medical devices firm ConvaTec reported an 8% increase in annual operating profit for last year, helped by an increase in margins that was ahead of target. ConvaTec shares traded up...
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Researchers successfully thaw cryopreserved tissue with no damage
A group of US scientists have successfully thawed cryopreserved tissue without damage to the sample, a huge step towards being able to use frozen or preserved tissues in transplantation, according to a...
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