Friday, July 25, 2014
Guided Therapeutics Files PMA Amendment with FDA for LuViva(R) Advanced Cervical Scan
NORCROSS, Ga., Jul 25, 2014 (BUSINESS WIRE) 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(R) Advanced Cervical Scan. The filing follows the face-to-face meeting the company had with the FDA in May 2014 and addresses questions raised in a September 6, 2013 not-approvable letter that the company received from the agency. We believe that our PMA amendment addresses the remaining questions the agency had about our application, said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. While we await a decision on the U.S. market, we continue to see momentum building in the larger international market where we are working to increase pilot studies with LuViva, drive sales and build market share. The FDA has 180 days to respond to the amendment. The company has regulatory approval to sell LuViva in Europe with the Edit
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