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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LivaNova said today that it won 510(k) clearance from the FDA for its family of Optiflow Arterial cannulae.
The London-based company touted its aortic arch cannula as providing improved hydrodynamics and boasting a novel dispersive tip that boosts blood flow characteristics and reduces wall shear stress profiles. Read more
New data from the Institute for Clinical and Experimental Medications found that gastric plication and GI Dynamics’ EndoBarrier device therapy showed similar outcomes for patients with type 2 diabetes and obesity.
“On a basic science and mechanistic basis, both treatments (GP and EndoBarrier) substantially improved metabolic parameters and were associated with reduction in systemic inflammation as well as adipose tissue inflammation,” Dr. Anna Cinkajzlova, who presented the data, said in a press release. “In addition, it is interesting to note that GP and EndoBarrier produced similar results despite radically different approaches. It is important to caution that these results represent early data from a retrospective non-randomized comparison and must be studied further in the future.” Read more
India’s drug pricing authority has given Abbott a year to pull its Xience Alpine drug-eluting stent from the market, according to an Indian Economic Times report.
The company approached India’s National Pharmaceutical Pricing Authority nearly a month ago looking to withdraw the device, citing price caps set on stents earlier this year. Read more
The 2.3% medical device tax imposed as part of the Affordable Care Act has a good chance of being repealed this year, according to an optimistic AdvaMed CEO Scott Whitaker.
In a press conference at AdvaMed’s Medtech conference in San Jose today, Whitaker was positive about the chances of the tax being repealed, and laid out 3 specific policy focuses for the industry group for the future: tax policy, regulatory changes and CMS payment issues. Read more
The U.S. FDA has been seeking to prevent shortages of medical devices and other products after disruptions caused by Hurricanes Harvey, Irma and Maria.
“These storms have hit hard in areas where there are a significant number of farmers, food distributors, and medical product manufacturers, including Houston, Florida, and now Puerto Rico and the U.S. Virgin Islands,” Dr. Scott Gottlieb, the FDA’s commissioner, said in a Sept. 22 announcement. Read more