Clik here to view.
NovoCure’s cancer therapy effective in late-stage study
(Reuters) – NovoCure (NSDQ:NVCR) said its lead cancer therapy improved survival rate in brain cancer patients in combination with Avastin in a late-stage study, sending its shares up 23% in extended...
View ArticleClik here to view.
FDA report: 510(k) applicants more responsive to additional information requests
By Stewart Eisenhart, Emergo Group Recent data from the US Food and Drug Administration shows that additional information requests (AI) for 510(k) medical device premarket notification applications...
View ArticleClik here to view.
Reva Medical mulls U.S. IPO next year
Reva Medical (ASX:RVA) is reportedly considering listing its shares on the U.S. stock market next year as it gears up to commercialize its Fantom absorbable stent. Reva, which is based in San Diego,...
View ArticleClik here to view.
Medtronic wins FDA panel date for DIAM spine stabilization system
Medtronic (NYSE:MDT) won a date with an FDA advisory panel for its DIAM spinal stabilization system. The federal safety watchdog’s Orthopaedic & Rehabilitation Devices panel is slated to meet Feb....
View ArticleClik here to view.
Angiodroid yanks 510(k) over FDA CO2 clearance issue
ADM Tronics Unlimited said last Friday Angiodroid Americas withdrew its FDA premarket notification 510(k) application for the Angiodroid CO2 injector for angiography over lack of clearance for CO2...
View ArticleClik here to view.
Dentsply-Sirona union passes FTC muster
Dentsply International (NSDQ:XRAY) and Sirona Dental Systems (NSDQ:SIRO) said their proposed, $5.56 billion merger-of-equals cleared the U.S. Federal Trade Commission’s waiting period, clearing the way...
View ArticleClik here to view.
NaviGate performs 1st-in-human transcath mitral valve replacement
Emerging heart valve-focused company NaviGate Cardiac Structures said it performed the 1st-in-human implant of its catheter-guided, mitral-valved stent. The company’s transcatheter mitral valve...
View ArticleClik here to view.
Weight Loss: BaroNova nets $36.5m in Series D
Weight loss company BaroNova said it closed a $36.5 million Series D round of financing for its TransPyloric Shuttle endoscopically delivered and retrievable weight-loss device. The round was led by...
View ArticleClik here to view.
MassDevice.com +3 | The top 3 medtech stories for November 23, 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...
View ArticleClik here to view.
Analysts: Worst case unlikely in Medicare call on Boston Scientific’s...
The worst-case Medicare reimbursement scenario for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device is unlikely to play out, according to a pair of analysts. Boston Scientific shares took a...
View ArticleClik here to view.
Pfizer’s $160B Allergan buy sparks cry for tax-inversion crack down
Pfizer (NYSE:PFE) said today it will buy Botox maker Allergan (NYSE: AGN) for approximately $160 billion and slash its tax bill in the largest-ever tax inversion to date. To avoid restrictions,...
View ArticleClik here to view.
FDA warns on intravascular device coating separation issues
The FDA said today that clinicians using intravascular medical devices such as catheters and guidewires should be aware of issues that can arise when their hydrophilic or hydrophobic lubricious...
View ArticleClik here to view.
UPDATE: Titan Medical reports $4m round, 1st-cadaver robotic Sport study
Updated with information from cadaver studies. Titan Medical (CVE:TMD) said today it closed a $4 million private placement round with Longtai Medical and said last week it performed its 1st successful...
View ArticleClik here to view.
IMBiotechnologies treats 1st patient in OCL 500 study
IMBiotechnologies said last week it treated the 1st patient in a clinical trial of its biodegradable OCL500 embolization microspheres to treat uterine fibroids. The OCL500 microspheres are designed to...
View ArticleClik here to view.
Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix (NSDQ:OCUL) said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication....
View ArticleClik here to view.
Mirowsky fights $6m legal tab in Medtronic spat
Mirowski Family Ventures, on the hook for a $6 million tab for Medtronic‘s (NYSE:MDT) legal costs, told a federal appeals court last week that a lower court misconstrued a 24-year-old deal with Eli...
View ArticleClik here to view.
Report: Medicare proposal would broaden coverage for Boston Scientific’s...
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified...
View ArticleClik here to view.
FDA plans Essure action for February
The FDA said today it will issue an evidence-based review of information on Bayer‘s (ETR:BAYN) controversial Essure permanent birth control for women in February next year. The agency said patient...
View ArticleClik here to view.
BSN Medical picks up compression therapy maker Wright Therapy Products
BSN Medical said today that it expanded its footprint in the lymphedema treatment market with the acquisition of Wright Therapy Products for an undisclosed amount. Hamburg, Germany-based BSN has been...
View ArticleClik here to view.
Cambridge Medical Robotics touts prototype, releases details on system
Cambridge Medical Robotics said today it completed construction and development of its 1st robotic surgical system prototype, and released details on the device it previously kept secret. The...
View Article
