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. Pulmatrix jumps 8% on rumors of potential Mylan takeover bid
Shares in Pulmatrix jumped more than 8% today on rumors that the company’s collaboration partner Mylan may be interested in a takeover bid.
In 2015, the 2 companies inked an ex-U.S. development deal for PUR0200, Pulmatrix’s investigational bronchodilator for the treatment of chronic obstructive pulmonary disease. Mylan had an option on the rights to the COPD candidate, but reportedly did not exercise it. Read more
4. NuVasive wins 1st FDA nod for CoRoent multi-level cervical implant
NuVasive Inc. said today that the FDA granted 510(k) clearance for its CoRoent small interbody implant for fusion procedures in the cervical spine, claiming it as the 1st U.S. nod for a cervical cage used at up to 4 levels.
The CoRoent device is an interbody cage made of PEEK-Optima polymer, designed to stabilize the cervical spinal during fusion. It’s hollow to allow autogenous and/or allogeneic bone grafts to be inserted. The FDA clearance covers the CoRoent small, small lordotic, small lordotic plus, small hyperlordotic and small contoured implants, San Diego-based NuVasive said. Read more
3. FDA readies overhaul of inspection program
The FDA is reportedly set to revamp its inspection program in a few months, according to Dr. Jeffrey Shuren, the director of the safety watchdog’s Center for Devices & Radiological Health.
Testifying before the House Energy & Commerce Committee yesterday, Shuren said the CDRH’s Office of Regulatory Affairs aims to improve its efficiency in conducting inspections of facilities where medical devices and drugs are made. Read more
2. ConvaTec investors deal 19% stake for more than $1B
The private equity owners of ConvaTec drummed up about $1.21 billion by selling off a 19% stake in the British medical device maker.
PE shops Nordic Capital and Avista sold 375 million shares at £2.60 apiece in the over-subscribed offering, after raising the float from 300 million shares, according to bookrunner UBS. Read more
1. Trump FDA pick to recuse himself from agency decisions involving 20 companies
Donald Trump’s nominee to head the FDA, Dr. Scott Gottlieb, reportedly told ethics officials at the Office of Government Ethics he plans to recuse himself for 1 year from agency decisions on more than 20 companies, including GlaxoSmithKline and Bristol-Myers Squibb.
Gottlieb has received millions of dollars for his roles as advisor, paid speaker and consultant to the companies, according to regulatory documents. He has also provided seed money for small, fledgling companies, advising them on regulatory matters. Read more
The post MassDevice.com +5 | The top 5 medtech stories for March 29, 2017 appeared first on MassDevice.
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