Category: Guided Therapeutics Inc.
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.
Here's a look at some of the top regulatory stories for medical device companies this week.
Guided Therapeutics asks the FDA for a face-to-face meeting to discuss the revival of its approval bid for the LuViva cervical scanner.
Guided Therapeutics (OTC:GTHP) said it's asked the FDA for a face-to-face meeting as it tries to resurrect the pre-market approval application for its LuViva cervical scanning device.