- Based on a meeting with the FDA that included a new lead reviewer, Guided Therapeutics (OTCQB:GTHP) says it now has the clarity it needs to prepare an approvable marketing application for its LuViva Advanced Cervical Scan device. Specific details of its plan to collect additional patient data should be finalized in the next several months.
- Possible approval is at least a year away to allow for the completion of the new study, the preparation and submission of the Premarket Approval Application (PMA) and the agency's review.
- The FDA has twice rejected the company's PMA, in May of this year and September 2013.
- The LuViva system is designed to immediately detect cervical pre-cancer without the need for a tissue sample (PAP smear). It is currently cleared for sale in Europe, Canada and Mexico.
- Previously: Guided Therapeutics to meet with FDA on November 30 to clarify requirements for PMA amendment for LuViva system (Nov. 5)
- Previously: Guided Therapeutics strikes out again with LuViva PMA (May 19)
Guided Therapeutics and FDA agree of path forward for LuViva marketing application, potential clearance more than a year away
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