Category: Food & Drug Administration (FDA)
The FDA has been busy so far in 2014, with a raft of new guidances and proposals with important implications for companies developing new medical devices and digital health products.
MASSDEVICE ON CALL — The FDA released a spate of new guidances in the 1st half of 2014, several with important implications for medical device and digital health companies.
Law360.com picked out some of the highlights from the year, including measures that affect how healthcare companies can communicate over social media and new rules that relax oversight of healthcare data systems and clinical decision software.
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).
FDA medtech regulators approve Medtronic's Prestige LP screw-free cervical disc for treatment of single-level cervical disc disease.
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.
After 2 failed attempts at FDA approval, Guided Therapeutics returns with an amended application for its LuViva cervical scanner.