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Catching up with the FDA's 2014 guidance | MassDevice.com On Call

July 30, 2014 by Arezu Sarvestani

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.com On Call

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.

Press Release: Medtronic receives FDA approval for prestige LP cervical disc system

July 29, 2014 by MassDevice

The Prestige LP cervical disc is Medtronic's third clinically-proven artificial cervical disc to receive FDA approval.

Press Release: Medtronic receives FDA approval for prestige LP cervical disc system

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).

Medtronic lands FDA approval to bring 3rd artificial cervical disc to the U.S.

July 29, 2014 by Arezu Sarvestani

FDA medtech regulators approve Medtronic's Prestige LP screw-free cervical disc for treatment of single-level cervical disc disease.

Medtronic lands FDA approval to bring 3rd artificial cervical disc to the U.S.

Press Release: Guided Therapeutics files PMA Amendment with FDA for LuViva Advanced Cervical Scan

July 29, 2014 by MassDevice

Press Release: Guided Therapeutics files PMA Amendment with FDA for LuViva Advanced Cervical Scan

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.

FDA bans medtech 510(k) pathway's 'split predicates'

July 29, 2014 by Arezu Sarvestani

Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary substantial equivalence claims between multiple devices.

FDA bans 510(k) pathway's 'split predicates'

Federal medical device regulators finalized a new guidance 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.

Guided Therapeutics finally re-files PMA for cervical scanner

July 28, 2014 by Arezu Sarvestani

After 2 failed attempts at FDA approval, Guided Therapeutics returns with an amended application for its LuViva cervical scanner.

Guided Therapeutics finally re-files PMA for cervical scanner
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