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. FDA bans medtech 510(k) pathway’s ‘split predicates’

Federal medical device regulators finalized a new rule this week that prohibits manufacturers from using so-called “split predicates” to establish that their new products are effectively the same as devices already on the market.

The rule, which is 2 years in the making, means that device makers can no longer reference separate predicate devices that have different intended uses when attempting to demonstrate “substantial equivalence.” Companies must now rely on a single predicate device or devices that have the same intended purpose. Read more

2. SoCal innovators team up for pediatric medical devices

MASSDEVICE ON CALL — Orange County, Calif., technology-backer OCTANe is teaming up with the Southern California Center of Technology & Innovation in Pediatrics (CTIP) to advance medical devices for chidren’s health.

OCTANe plans to set up shop at the Children’s Hospital of Las Angeles (CHLA), which operates the CTIP, to help commercialize new pediatric device with its “LaunchPad process of predictive analytics-based acceleration.” Read more

1. Bard settles more than 500 pelvic mesh complaints

C.R. Bard managed to close the books on a large chunk of patient complaints against its Avaulta mesh implant, settling more than 500 cases in its 2nd quarter.

The company didn’t say just how much it settled for, but reported that it paid $259 million in total during the quarter to cover undefined “product liability matters.” Read more