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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Intrinsic Therapeutics said today that it raised a $49 million debt-and-equity round for the Barricaid annular closure device for discectomies that it’s developing.
The Boston-based company said the round consisted of a $28 million equity financing led by New Enterprise Assoc. and Delos Capital, plus a $21 million debt facility with CRG. Other backers included Greenspring Associates, Quadrille Capital and a “corporate strategic,” Intrinsic said. Read more
Medtronic said today that it won pre-market approval from the FDA for its line of quadripolar, MRI-safe cardiac resynchronization therapy pacemakers.
The approval covers Medtronic’s Percepta, Serena and Solara devices, the Fridley, Minn.-based company said. The devices are slated tho hit the U.S. market in “early summer,” Medtronic said. In February the company said it had won CE Mark approval in the European Union for the MRI-safe quad pacer line and planned a March debut. Read more
A federal appeals court yesterday upheld a win for Boston Scientific in a product liability lawsuit brought over its Uphold pelvic mesh.
Plaintiff Martha Carlson alleged that her injuries were caused by the Uphold product after its implantation in 2010 in a Charlotte hospital. But the U.S. District Court for Western North Carolina found in October 2016 that Carlson failed to prove that Boston Scientific “acted unreasonably in designing and/or formulating the Uphold device proximately causing Martha Carlson’s injuries,” according to court documents. Read more
The U.S. Senate voted 57-42 yesterday to confirm Dr. Scott Gottlieb as commissioner of the FDA.
Gottlieb, 44, is a former FDA deputy commissioner who has advocated a loosening of requirements needed for approval of new medical products. He is also a resident fellow at the conservative American Enterprise Institute think tank, a partner at venture capital firm New Enterprise Assoc., and sits on the boards of multiple healthcare companies. The Senate Health, Education, Labor & Pensions Committee approved Gottlieb on a 14-9 vote last month. Read more
The former vice president of R&D for drug-coated balloon maker Lutonix, Christopher Barry, yesterday pleaded guilty to a single count of trade secret theft in federal court in Minneapolis.
Barry, who left Lutonix in 2015 to become CEO of Urotronic, admitted to downloading 6 files in April 2015 containing trade secrets about the development of the drug coating for the Lutonix balloon and transferred the files to his work computer at Urotronic. C.R. Bard paid $325 million to acquire Lutonix in December 2011. Read more