Kevin King, CEO of Silicon Valley digital health company iRhythm, tells MassDevice about the promise of Big Data and how remote patient monitoring can reveal intricate details of the habits of the heart.
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 Prestige LP cervical disc is Medtronic's third clinically-proven artificial cervical disc to receive FDA approval.
MEMPHIS, TENN. - Medtronic, Inc. (NYSE: MDT) announces that it has received approval from the U.S. Food and Drug Administration (FDA) to market the PRESTIGE® LP Cervical Disc System for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy).
NORCROSS, Ga. -- Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) today announced that it has filed an amendment to its premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the LuViva Advanced Cervical Scan.
Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary substantial equivalence claims between multiple devices.
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.