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 news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Nephros inks distro deal with CS Medical
Nephros said today it signed a distribution agreement with CS Medical to distribute Nephros’ DSU-H ultrafilter as an option with CS Medical’s TD 100 automated trans-esophageal echocardiogram probe disinfector.
The DSU-H filter from Nephros has FDA 510(k) clearance and is designed to provide ultrapure water as an aid in infection prevention and control, CS Medical said. Read more
4. FDA slaps Class 1 label on Medtronic Capnostream battery pack recall
The FDA today labeled Medtronic‘s voluntary recall of battery packs used with its Covidien Oridion labeled Capnostream 20 and 20p patient monitors as Class I.
The devices are being recalled due to a defect causing an increased risk of thermal damage in the packs. Read more
3. Senate bill looks to streamline CMS pathway for “breakthrough” devices
The U.S. Senate has introduced a bill to expedite Centers for Medicare and Medicaid Services decision making for new medical devices.
The bill, titled the “Ensuring Patient Access to Critical Breakthrough Product Act” will help “bridge a gap” between the FDA and CMS and “improve patient access to breakthrough medical technologies,” according to a new report from medical device industry group Advamed. Read more
2. Novartis pharma head Epstein steps away, most recent in string of top-level turnovers
Novartis is facing an upheaval in its top management, seeing 7 departures over the last 5 months as shares fell 25% since last July. Read more
1. Fighting opioid addiction with medical devices: FDA approves new implant
The FDA today cleared a new opioid-addiction fighting implant from Braeburn Pharmaceuticals, the 1st of its kind to win a nod from the federal watchdog.
The matchstick-sized Probuphine implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies. Read more
