Category: Guided Therapeutics Inc.Syndicate content

FDA denies Guided Therapeutics again

May 20, 2015 by Brad Perriello

The FDA sends its 3rd 'not approvable' letter to Guided Therapeutics over its pre-market approval application for the LuViva cervical scanner.

FDA issues 3rd denial of Guided Therapeutics' LuViva

Guided Therapeutics eyes China with $775k share sale

April 27, 2015 by Brad Perriello

Guided Therapeutics raises $775,000 from Chinese investors to pursue distribution in the People's Republic for its LuViva cervical scanner.

Guided Therapeutics eyes China with $775k share sale

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.

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

Guided Therapeutics lands Mexico OK, creeps toward FDA resubmission

July 14, 2014 by Arezu Sarvestani

Beleaguered Guided Therapeutics touts Mexican approval for its LuViva Advanced Cervical Scan as the company carefully prepares an amended application to the FDA.

Guided Therapeutics lands Mexico OK, creeps toward FDA resubmission

Guided Therapeutics takes another swing at FDA approval with amended PMA

May 14, 2014 by Arezu Sarvestani

Twice scorned device maker Guided Therapeutics prepares to amend its application for premarket approval after the FDA in September rejected the company's original bid.

Guided Therapeutics takes another swing at FDA approval with amended PMA

Guided Therapeutics gets its day with the FDA

April 11, 2014 by Arezu Sarvestani

As requested, Guided Therapeutics gets a sit-down with the FDA to discuss a renewed bid to land approval for its LuViva cervical scanner.

Guided Therapeutics gets its day with the FDA

Guided Therapeutics (OTC:GTHP) is getting its requested date with the FDA's medical device regulators, during which the company hopes to revive its rejected bid to win approval for the LuViva cervical scanner.