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MassDevice.com +3 | The top 3 medtech stories for February 8, 2016
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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US FDA prioritizes devices requiring human factors reviews
By Stewart Eisenhart, Emergo Group US medical device regulators have specified types of devices for which premarket application submissions should include human factors testing information, according...
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FDA wants answers from Medtronic, St. Jude on leadless pacers
The FDA is hosting a panel meeting on leadless pacemaker devices, looking to St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) to join the discussion and make recommendations on acceptable...
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Battling doctor shortage, Indian hospitals offer intensive care from afar
(Reuters) – A doctor at a hospital in India’s capital, New Delhi, was recently tracking a wall of monitors displaying the vital signs of intensive care patients admitted hundreds of miles away when...
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Cell Applications, Cyfuse launch 3D bioprinting method in North America
Cell Applications and Cyfuse Biomedical K.K. announced the North American launch of a new 3D bioprinting technique to create 3D tissue from cells utilizing Cyfuse’s robotic Regenova 3D bioprinter. San...
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Bio-Rad picks up cytometer platform from Propel
Bio-Rad Laboratories (NYSE:BIO) said today it acquired Propel Labs high performance analytical flow cytometer platform, with a planned instrument launch from the acquisition later this year. Flow...
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Mexican regulators boosting 3rd-party review process for medical devices
By Stewart Eisenhart, Emergo Group Mexico’s medical device market regulator COFEPRIS has slated efforts to improve its third-party review (TPR) process and reduce registration timeframes for 2016....
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Boston Scientific wins CMS coverage for Watchman LAAC
Boston Scientific (NYSE:BSX) said late yesterday it won coverage from the Centers for Medicare and Medicaid Services for left atrial appendage closure therapies using its Watchman device. The device...
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CorMatrix wins FDA nod for Tyke neonate cardiac tissue
CorMatrix Cardiovascular said today it won FDA 510(k) clearance for its Tyke biomaterial for use in neonates and infants. The patch is designed to repair pericardial structures and as an epicardial...
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Mobile health buys: Moseda acquires CareKit Health
Mobile health firm Moseda Technologies said today it acquired CareKit Health Co., developers of a software platform that allows complex patients to receive healthcare in their homes. CareKit’s platform...
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LifeWatch wins FDA nod for vital sign monitoring
Swiss remote diagnostic monitoring company LifeWatch said today it received FDA 510(k) clearance for its Vital Signs monitoring service. The service operates using wireless, patch-based vital signs...
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Medtronic launches Valiant TAAA stent graft study
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in a clinical study of its Valiant TAAA stent graft system designed as a minimally invasive treatment for thoracoabdominal aortic aneurysm....
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Proven Process, Innoblative Designs partner for novel ablation device
Proven Process Medical Devices said today it was selected by novel ablation developer Innoblative Designs to act as a partner to develop and manufacture their ablation device. Innoblative, originally...
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MassDevice.com +3 | The top 3 medtech stories for February 9, 2016
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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Technimark launches medical component manufacturer biz
Pritzker Group Private Capital subsidiary and custom rigid plastic packaging and component maker Technimark said today it is launching a new medical division titled Technimark Healthcare. The launch...
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Axinesis wins CE Mark for robotic rehab device
Axinesis said today it won CE Mark approval in the European Union for its REAPlan medical interactive robot device designed to rehabilitate impaired upper limbs in stroke victims and children with...
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Smith & Nephew inks distro deal with OrthAlign
OrthAlign said today it inked a multi-country agreement with Smith & Nephew (NYSE:SNN) to distribute OrthAlign’s KneeAlign total knee arthroplasty devices. Through the deal, Smith & Nephew...
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Building a case for medical device interoperability: FDA’s call to action
By: Bakul Patel, M.S., M.B.A. As Yoda might say: build a case for interoperability, we must. While we may not have yet realized the technological accomplishments of Yoda’s advanced world, today...
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GW Plastics expands medical device contract manufacturing capabilities
GW Plastics, a leader in precision injection molding and contract manufacturing to the healthcare market, announced today at the MD&M West 2016 Exposition in Anaheim, CA the completion of a major...
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Stryker buys Synergetics neuro assets
Stryker (NYSE:SYK) said today it agreed to acquire the entirety of Synergetics (NSDQ:SURG) neuro portfolio for an undisclosed amount. The buy puts Synergetics Malis generator, Malis disposable forceps...
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