FDAnews
www.fdanews.com/articles/148200-fda-guided-therapeutics-unveil-plan-for-rejected-luviva-cervical-scanner-pma

FDA, Guided Therapeutics Unveil Plan for Rejected LuViva Cervical Scanner PMA

July 26, 2012
Guided Therapeutics 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.
Mass Device