'Not-Approvable' Letter Fits Trend For Optical Cancer Detectors, Guided Therapeutics Says
This article was originally published in The Gray Sheet
Executive Summary
The company's response to an FDA not-approvable letter for its LuViva cervical cancer scanner will be guided by the experiences of other light-based cancer detector developers that encountered the same initial setback. The firm's likely next step: petitioning FDA for an advisory panel meeting.