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. MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. Read more
4. ADA 2017 Roundup: Photo ban causes stir among conference attendees
Many scientific conferences have embraced the technological age, creating hashtags for attendees to share content on Twitter and engage with one another. Some conferences even acknowledge attendees with powerful social media presences by giving them special ribbons and including their Twitter handles on their name badges.
But at this year’s meeting of the American Diabetes Association’s, the conference’s official hashtag was dominated by angry attendees protesting a seemingly old-school policy: attendees were not allowed to post photos from presentations on Twitter. Read more
3. Electromed settles Medicare beef for $1m
Electromed said last week that it settled a beef with the Centers for Medicare & Medicaid Services for roughly $1 million.
New Prague, Minn.-based Electromed, which makes the SmartVest airway clearance system, said the dispute arose over some 700 Medicare fee-for-service claims it submitted from 2012 through 2015, totaling about $2.9 million. After the government health insurer rejected the claims, Electromed asked for an administrative law judge hearing to reconsider the claims, according to a regulatory filing. Read more
2. Anti-trust regulators want more from BD, Bard on $24B merger
Becton Dickinson & Co. and C.R. Bard said last week that the U.S. Federal Trade Commission wants more information on their pending $24 billion merger.
The move adds 30 days to the timeline for closing the $317-per-share deal, the companies said, but the acquisition is still slated to close in the fall. Read more
1. J&J’s Ethicon wins Philly pelvic mesh trial
A Pennsylvania state court jury reportedly cleared Johnson & Johnson subsidiary Ethicon in the 4th pelvic mesh bellwether to go to trial in Philadelphia, despite finding that the company’s TVT-Secur product was defectively designed and that Ethicon failed to warn of its risks.
Kimberly Adkins sued in 2013, alleging that the TVT-Secur mesh she was implanted with in July 2010 to treat urinary incontinence caused her injuries. After a 12-day trial, a jury in the Philadelphia Court of Common Pleas agreed with Adkins’ defective design and failure to warn claims, the panel decided that her injuries were not caused by the device, according to news reports. Read more