Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
The FDA said that Insulet last month recalled 18 lots of its flagship OmniPod insulin management system due to a needle deployment issue.
No serious injuries or deaths were reported as a result of the problem, revealed by a slight increase in reports of failed or delayed needle deployment. The reported incidence is 1% to 2%, the federal safety watchdog said. Insulet notified customers Nov. 2, the FDA said. Read more
Zimmer Biomet said that the FDA granted an expanded safety claim for its Gel-One cross-linked hyaluronate knee injection indicating that the treatment is safe to use more than once.
Gel-One is used to treat knee osteoarthritis that hasn’t responded to non-drug therapy, non-steroidal anti-inflammatory drugs or simple analgesics, Warsaw, Ind.-based Zimmer Biomet said. It’s designed to help lubricate the knee joint, the company said. Read more
Medtronic said that it tapped Henry Schein to be its exclusive distributor for some Type II diabetes products in the U.S.
Fridley, Minn.-based Medtronic said the Henry Schein Medical business will distribute the products to primary care physicians here, including its iPro2 Professional continuous glucose monitor and the i-Port Advance injection port. Read more