FDA spikes Guided Therapeutics PMA, company asks for independent review
January 25, 2012 by MassDevice staff
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 The federal watchdog agency wants additional clinical data on a newer version of the device, according to Guided Therapeutics president & CEO Mark Faupel.
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