- 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.
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