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Guided Therapeutics files LuViva PMA amendment

  • 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.
Comments (1)
  • Joe2922
    , contributor
    Comments (442) | Send Message
    Luviva has been approved in 27 nations with several more pending.
    See IV message board for quick links to company website-news, recent Markum CEO presentation audio/visual, etc:
    Sales are expected to quadruple in 2015 compared to 2nd quarter 2014; company guidance is $4-8M. 90% margins on single-use disposables.
    28 Jul 2014, 03:25 PM Reply Like
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