Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
3. Internal FDA disputes may affect regulatory outcomes for medical devices
The FDA’s Center for Devices & Radiological Health needs better conflict management procedures to guide device reviewers on scientific disputes that may affect regulatory decisions, according to a report from the Dept. of Health & Human Services’ Office of the Inspector General.
2. Cordis issues “urgent” recall on Fire Star Rx balloon catheters
Johnson & Johnson subsidiary Cordis Corp. issues an "urgent product recall" on a certain lot of its Fire Star Rx PTCA dilation catheters over a potential for "slow deflation" or "no deflation."
1. U.S. approves J&J’s $21B offer for Synthes with caveats, deal may close this week
Johnson & Johnson wins U.S. approval for a $21.3 billion acquisition of Swiss orthopedic device giant Synthes, positioning the merger to close as early as this week – as long as J&J sells its wrist fracture treatment business to Biomet.
