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. Si-Bone wins Nebraska BCBS coverage for iFuse implant system
Si-Bone said today Blue Cross Blue Shield of Nebraska updated its medical policy to provide coverage for minimally invasive SI joint fusion procedures.
The move makes BCBS of Nebraska the 2nd BCBS plan, following BCBS of Michigan, to approve a positive coverage policy for MIS SI joint fusion procedures, San Jose, Calif.-based Si-Bone said. Read more
4. DePuy Synthes recalls select medical power tool battery packs over explosion risk
Johnson & Johnson subsidiary DePuy Synthes initiated a select recall of power tool system battery adaptors due to possible explosion risks, according to an FDA notice posted today.
The federal watchdog labeled the recall as a Class I, the most serious type of recall issued, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death.” Read more
3. Edwards Lifesciences wins CE Mark for Inspiris Resilia aortic valve
Edwards Lifesciences said today it won CE Mark approval in the European Union for its Inspiris Resilia aortic valve.
The Irvine, Calif.-based company said the valve is the 1st in a “new class of resilient heart valves” which incorporate its Resilia tissue and features a Perimount Magna ease valve and VFit technology for future valve-in-valve procedures. Read more
2. Misonix reports Chinese distributor to SEC, DOJ over possible FCPA issues
Misonix this week reached out to the Securities and Exchange Commission and the U.S. Department of Justice over possible issues with the Chinese distributor of its products, according to an SEC filing posted today.
The company said that on Sept. 27 and Sept. 28, respectively, it contacted the SEC and DOJ to “voluntarily inform” them that it may have “had knowledge of certain business practices of the independent Chinese entity that distributes its products in China, which practices raise questions under the Foreign Corrupt Practices Act. Read more
1. Intuitive Surgical inks R&D JV deal with Fosun Pharma for catheter-based robotic systems
Robotic surgery giant Intuitive Surgical said today it inked a joint venture deal with Shanghai Fosun Pharmaceutical to research, develop, manufacture and sell robotic-assisted catheter-based medical devices.
Both companies will contribute $100 million to start the joint venture, which will initially focus on development of early diagnostics and cost-effective treatments for lung cancer, one of the most commonly diagnosed forms of cancer in the world. Read more
The post MassDevice.com +5 | The top 5 medtech stories for September 29, 2016 appeared first on MassDevice.
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