Category: Guided Therapeutics Inc.
The FDA sends its 3rd 'not approvable' letter to Guided Therapeutics over its pre-market approval application for the LuViva cervical scanner.
Guided Therapeutics raises $775,000 from Chinese investors to pursue distribution in the People's Republic for its LuViva cervical scanner.
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.
After 2 failed attempts at FDA approval, Guided Therapeutics returns with an amended application for its LuViva cervical scanner.
Beleaguered Guided Therapeutics touts Mexican approval for its LuViva Advanced Cervical Scan as the company carefully prepares an amended application to the FDA.
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.
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 (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.