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.
3. Guided Therapeutics finally re-files PMA for cervical scanner
Guided Therapeutics is ready to take another shot at FDA approval for its cervical scanner with an amended premarket approval application back in the agency’s hands.
Nearly a year after receiving the 2nd non-approvable letter for its flagship LuViva cervical scanner, Guided Therapeutics filed a new PMA last week with high hopes. The FDA has 180 days to respond to the company’s new application. Read more
2. Johnson & Johnson loses bids to dismiss Pinnacle bellwethers
A federal judge in Texas this month shot down bids by Johnson & Johnson to dismiss a pair of bellwether lawsuits in the multi-district litigation over its Pinnacle metal-on-metal hip implant, setting the stage for the cases to go to trial in September.
Judge Ed Kinkeade of the U.S. District Court for Northern Texas is presiding over the MDL of more than 6,000 lawsuits filed by patients implanted with the Pinnacle device. Johnson & Johnson moved to dismiss the 1st 2 bellwether cases, Lay v. DePuy Orthopaedics Inc. et al. and Herlihy-Paoli v. DePuy Orthopaedics, Inc., et al., arguing that the Texas court lacks jurisdiction because the cases were originally filed in Montana. Read more
1. Medtronic pays up to $105 million for Visualase
Medtronic said today that it paid up to $105 million to acquire Visualase and its MRI-guided laser neurosurgery device.
The deal calls for Medtronic to pay $70 million up front, plus another $35 million in milestone payments, according to a press release. Read more