Guided Therapeutics, Inc. Provides Update on PMA Application for LuViva® Advanced Cervical Scan and Timing for Filing of CE Mark
1/23/2012 6:09:51 AM
NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) today announced that the company plans to seek an independent panel review of its Pre-market Approval (PMA) application for the LuViva® Advanced Cervical Scan from the U.S. Food and Drug Administration (FDA) after receiving a not-approvable letter from the agency. Meanwhile, the company plans to work with FDA to address the outstanding issues so that they can be successfully resolved.