Category: Guided Therapeutics Inc.
Guided Therapeutics signs distribution deals to gain access to 86 million new potential patients, hoping to land a win after the FDA refused to accept the company's premarket approval application.
Georgie-based Guided Therapeutics (OTC:GTHP) hasn't won many points after announcing increased distribution for its LuViva advanced cervical scanning system.
Guided Therapeutics shares drop nearly 20% as the company faces more regulatory setbacks in getting its LuViva advanced cervical scanning system onto the U.S. market.
AngioDynamics lets U.S. sales general manager Alan Panzer go "without cause."
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.
Guided Therapeutics will take development of its esophageal cancer detection device in-house under the terms of new deal with Konica Minolta.
Guided Therapeutics (OTC:GTHP) and its largest customer, Konica Minolta (TYO:4902), agreed to alter a development deal for an esophageal cancer detection device.
Guided Therapeutics and the FDA agree on a plan to rework an approval bid for the medical device company's once-rejected LuViva cervical scanning system.
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.
Guided Therapeutics wants an independent panel to review the pre-market approval application for its LuViva cervical scan, after the FDA issues a "not-approvable" letter, and files for CE Mark approval in the European Union.
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 The federal watchdog agency wants additional clinical data on a newer version of the device, according to Guided Therapeutics president & CEO Mark Faupel.