Guided Therapeutics Inc.
Guided Therapeutics wants a sit-down with FDA
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.
Philips promotes home health chief to North America CEO | Personnel Moves
Guided Therapeutics widens distribution after FDA disappointment
Georgie-based Guided Therapeutics (OTC:GTHP) hasn’t won many points after announcing increased distribution for its LuViva advanced cervical scanning system.
More FDA hurdles for cervical scanning system sink Guided Therapeutic shares
AngioDynamics lets sales manager Panzer go | Personnel Moves
keys: angiodynamics, cfo, alan panzer
Albany, N.Y.-based AngioDynamics (NSDQ:ANGO) said Alan Panzer, its general manager of U.S. sales, will no longer be with the company as of July 31, 2013.
Cancer: Guided Therapeutics, Konica Minolta in esophageal cancer pact
Guided Therapeutics (OTC:GTHP) and its largest customer, Konica Minolta (TYO:4902), agreed to alter a development deal for an esophageal cancer detection device.
FDA, Guided Therapeutics unveil plan for rejected LuViva cervical scanner PMA
Guided Therapeutics (OTC:GTHP) made new progress on its once-rejected pre-market approval bid for the LuViva advanced cervical cancer scanning system, which the FDA knocked with a "not approvable" letter in January.
Bovie swings to 2011 black | Earnings Roundup
FDA spikes Guided Therapeutics PMA, company asks for independent review
Guided Therapeutics (OTC:GTHP) said it plans to ask an independent panel to review a pre-market approval application to the FDA for its LuViva advanced cervical scan after receiving a “not-approvable” letter from the agency.
The LuViva device scans the cervix with light to check for indicators of pre-cancer below the surface of the cervix. The federal watchdog agency wants additional clinical data on a newer version of the device, according to Guided Therapeutics president & CEO Mark Faupel.
Medtronic enrolls first patient in Fire & Ice ablation study | Regulatory Roundup
Medtronic (NYSE:MDT) enrolled the first of up to 572 patients in its Fire & Ice trial, the largest clinical study to date to compare 2 atrial fibrillation ablation systems.