FDA, Guided Therapeutics unveil plan for rejected LuViva cervical scanner PMA
Guided Therapeutics and the FDA agree on a plan to rework an approval bid for the medical device company's once-rejected LuViva cervical scanning system.
Guided Therapeutics (OTC:GTHP) made new progress on its once-rejected pre-market approval bid for the LuViva advanced cervical cancer scanning system, which the FDA knocked with a "not approvable" letter in January.
The medical device company met with the FDA earlier this month to develop a path forward to pre-market approval for LuViva, a non-invasive scanning system designed to detect disease that leads to cervical cancer.
The FDA in January refused Guided Therapeutics' original PMA bid, asking that the company provide additional data on a newer version of the device and make some changes to the study parameters.