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. Serious medical device recalls nearly doubled in Q2
Medical device recalls at the Class I level were up 88% during the second quarter of 2017, and the major culprit was quality issues involving device part malfunctioning, according to a new report from Stericycle ExpertSolutions.
Quality played a significant role among the 15 serious medical device recalls during the second quarter, partly because it encompasses such a host of problems including failure to establish durability, approving products before they were ready, and poor quality of components. Read more
4. Report: Indian regulator echoes warnings on Abbott’s Absorb resorbable stent
Indian health regulators reportedly echoed the warning on using the Absorb bioresorbable stent made by Abbott in too-small coronary vessels.
Data unveiled in March at the annual conference of the American College of Cardiology showed that Absorb confers a higher risk of serious adverse events at two years compared with the company’s Xience drug-eluting stent, according to new data from a study that prompted the FDA to warn physicians on the risk. In response Abbott curtailed use of the device in Europe. Read more
3. Zimmer Biomet slips on HHS subpoena
Investors punished Zimmer Biomet yesterday by pushing its share price down nearly 2% after the company revealed a subpoena from the U.S. Health & Human Services Dept.
In a regulatory filing yesterday, the Warsaw, Ind.-based orthopedics giant said that the HHS Office of the Inspector General in June requested “a variety of records primarily related to our healthcare professional consulting arrangements (including in the areas of medical education, product development, and clinical research) for the period spanning January 1, 2010 to the present.” Read more
2. Intuitive Surgical licenses JustRight’s robotic sealing, stapling tech
Intuitive Surgical inked a license on the miniaturized robotic sealing and stapling technology developed by JustRight Surgical that includes an unspecified equity investment and joint product development program.
Louisville, Colo.-based JustRight raised an $11 million Series B round early last year and later won 510(k) clearance from the FDA for its 3mm pediatric vessel-sealing system. Read more
1. Bard shareholders approve $24B merger with BD
Shareholders in C.R. Bard yesterday overwhelmingly approved a $24 billion merger with Becton Dickinson & Co.
The $317-per-share deal, which was announced last April, is expected to close during the fourth quarter, the companies said. Read more
