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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Cardiovascular Systems (NSDQ:CSII) escaped a purported class-action lawsuit brought over allegations that it ran an off-label promotion and kickbacks scheme, but the reprieve could be short-lived because the case was dismissed without prejudice.
St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 that accused CSI of inducing physicians to use its products by offering free, all-expense-paid training programs “followed by explicit demands by CSI employees that attendees use CSI products on future patients,” giving away product for free, 3rd-party referral channel marketing, and “sham Speaker Bureau payments for high-prescribers and others whom CSI sought to cultivate,” according to the complaint. Read more
A bill introduced yesterday in the U.S. Senate would reform the way Medicare agencies make local coverage determinations in a bid to make the process more transparent.
The bipartisan bill, S. 794, sponsored by Sen. Johnny Isakson (R-Ga.) and co-sponsored by Sens. Thomas Carper (D-Del.), Debbie Stabenow (D-Mich.) and John Boozman (R-Ark.), would change the way Medicare Administrative Contractors make LCDs for medical devices, according to the Advanced Medical Technology Assn. Read more
Vascular Dynamics said this week that it closed a private placement worth $10.4 million that it plans to use on the clinical program for its MobiusHD device for treating drug-resistant hypertension.
The MobiusHD implant is designed to reshape the carotid sinus to amplify the signals for baroreceptors lining the blood vessel. Implanted percutaneously, it’s designed to stimulate vasodilation. Read more
Medtech industry lobbying group AdvaMed will maintain its focus on pursuing a full repeal of the medical device tax, no matter what form the repeal takes, according to newly appointed AdvaMed chair and CVRx prez & CEO Nadim Yared.
Yared, who was appointed to his position early last week, said the organization “is not in a position to propose where to tie in” a repeal of the tax, and that whatever form the repeal comes, the group will “probably take it.” Read more
Boston Scientific is a potential acquirer for mitral valve maker Neovasc, according to JMP Securities analyst John Gillings, after agreeing to a $435 million deal for aortic valve maker Symetis that doesn’t include its Middle Peak Medical mitral valve assets.
Although the all-cash Symetis deal adds the market-ready Acurate transcatheter aortic valve implant to Boston Scientific’s structural heart portfolio, interventional cardiology president Kevin Ballinger told analysts during a conference call that the Middle Peak assets don’t fit in with its other programs. Read more