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 gave the green light to Covidien’s Nellcor portable SpO2 monitor, which is used to monitor oxygen and pulse levels in the home.
The Nellcor device can be used to monitor adults and babies at risk for respiratory distress and to help screen infants for critical congenital heart disease. Read more
Federal prosecutors are fighting a bid by Doug DeCinces, the ex-Orioles player accused of insider trading on information he got from former Advanced Medical Optics CEO James Mazzo, to have a raft of charges dropped from his indictment.
Mazzo is accused of tipping DeCinces about the $2.8 billion acquisition of AMO by Abbott and of AMO’s 2007 buyout of IntraLase. In 2012 federal prosecutors accused DeCinces of passing the inside information along to friends to make up for bad investment advice he’d given them previously. Read more
A sharply divided FDA advisory panel recommended that the watchdog agency subject high-tech replacement heart valves to its most-rigorous pre-market approval protocol, meaning the CryoValve allograft made by CryoLife must undergo the PMA process.
The CryoValve pulmonary valve is the only such device on the U.S. market; CryoLife won clearance via the FDA’s 510(k) program for Class II “moderate-to-high risk” devices. Class III or “high-risk” devices must to use the PMA process, which requires more clinical trial data to back the application. Read more