Guided Therapeutics (OTC:GTHP) said today the FDA granted a request to reschedule a meeting to discuss its stalled bid for pre-market approval for its LuViva cervical scan device. Norcross, Ga.-based Guided Therapeutics said it’s now scheduled to meet with the FDA on Nov. 30 to discuss its plans to submit the application for the cervical scan device. […]
Guided Therapeutics Inc.
Guided Therapeutics wins an FDA date for LuViva device
Guided Therapeutics (OTC:GTHP) said today that it won a date with the FDA to discuss its stalled bid for pre-market approval for the LuViva cervical scan device. Norcross, Ga.-based Guided Therapeutics said it’s slated to meet Nov. 6 with the FDA to review its proposal for new clinical data on the LuViva device. GTHP shares lost ⅓ of […]
Guided Therapeutics presses on in Costa Rica despite FDA setbacks
Guided Therapeutics (OTC:GTHP) said today it launched its LuViva cervical scanning system in Costa Rica, despite continued struggles to get the device approved in the U.S. A Costa Rican pilot program using LuViva, which is designed to scan the cervix for chemical and structural indicators of pre-cancerous tissue, is slated to begin in the coming weeks, the Norcross, […]
Guided Therapeutics pushes LuViva PMA bid
Guided Therapeutics (OTC:GTHP) said today that it pushed its bid for pre-market approval for its LuViva from the FDA, after the U.S. safety watchdog handed it another setback last spring. GTHP shares lost ⅓ of their value May 20 after the FDA asked Norcross, Ga.-based Guided Therapeutics for more data on the LuViva device, which is designed to scan […]
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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
Guided Therapeutics lands Mexico OK, creeps toward FDA resubmission
Guided Therapeutics takes another swing at FDA approval with amended PMA
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.