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.
Boston Scientific said that it’s launched a global clinical trial for its Emblem S-ICD in primary prevention patients with severely reduced cardiac function.
The Untouched study is slated to enroll a minimum of 2,015 patients with no documented, life-threatening arrhythmic event who are at risk of sudden cardiac death. The 18-month study will compare outcomes with the performance markers set out in the Madit-RIT trial of transvenous ICDs, Boston Scientific said. Read more
A bipartisan U.S. Senate duo introduced a bill that would reform the way the FDA approves medical devices.
The “FDA Device Accountability Act,” introduced by Sens. Al Franken (D-Minn.) and Richard Burr (R-N.C.), would require the FDA to use the “least burdensome” requirement contained in the the FDA Modernization Act of 1997, according to a press release. Read more
Medtronic announced its 2nd acquisition of the day, saying it paid $110 million to acquire Aptus Endosystems and its Heli-FX device aortic securement device.
Earlier the Fridley, Minn.-based medical device giant said it picked up CardioInsight for $93 million. Read more