Guided Therapeutics files LuViva PMA amendment

|About: Guided Therapeutics, Inc. (GTHP)|By:, SA News Editor

In response to the FDA's September 6, 2013 not-approvable letter, Guided Therapeutics (OTCQB:GTHP +0.8%) files an amendment to its PMA application for the LuViva Advanced Cervical Scan. The company believes it addresses all the agency's questions.

The regulator has 180 days to respond.

LuViva is currently approved for sale in Europe, Mexico, Canada and Singapore.