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. Final FDA rules clarify adverse event reporting for contract manufacturers
The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burden for contract manufacturers.
The federal safety watchdog’s draft guidance for “Medical Device Reporting for Manufacturers,” issued in July 2013, put both the contract manufacturer and its customer on the hook for reporting adverse events. Read more
4. Sofregen buys Allergan’s Seri surgical scaffold
Sofregen Medical said today that it bought the Seri surgical scaffold from Allergan for an undisclosed amount. Polaris Partners and other investors provided financing for the acquisition, according to the Medford, Mass.-based company.
Seri, which is approved by the FDA for use as soft tissue support in plastic and reconstructive surgical procedures, is the only approved silk-based surgical mesh on the market. Allergan acquired the technology when it bought Serica Technologies in 2010, a spinout from Tuft University’s biomedical engineering lab run by David Kaplan and Fiorenzo Omenetto. Read more
3. LeMaitre Vascular pays $14m for Restore Flow Allografts
LeMaitre Vascular said last week that it agreed to put up $14 million for tissue preservation service provider Restore Flow Allografts.
The deal calls for Burlington, Mass.-based LeMaitre to pay $12 million up front and another $2 million in May 2018, plus earn-puts pegged to sales performance over the next 2 years. Read more
2. FDA approves Medtronic’s Claria MRI quad CRT-D
Medtronic said today that it won pre-market approval from the FDA for its Claria MRI quad cardiac resynchronization therapy defibrillator for magnetic resonance imaging scans at both 1.5 and 3 Tesla.
“The Claria MRI CRT-D is our latest innovation to help improve patients’ response to CRT, establishing a new level of personalized care,” heart failure GM Dr. David Steinhaus said in prepared remarks. “And it further expands our industry-leading MR-conditional portfolio of devices, which are helping to improve the lives of more patients throughout the world.” Read more
1. Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose. Read more
The post MassDevice.com +5 | The top 5 medtech stories for November 14, 2016 appeared first on MassDevice.
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