LuViva Advanced Cervical Scan regulatory update

Guided Therapeutics submitted an amendment to its PMA for LuViva Advanced Cervical Scan to detect cervical disease that leads to cancer. The amendment includes additional analysis requested by the agency. In May, the company submitted a response to a January not approvable letter that included information requested by FDA and a request for a meeting with the agency to determine a path forward for approval. In the meeting in July, Guided Therapeutics had agreed to submit an amendment to address FDA's questions stemming from the not approvable letter (see BioCentury, Jan. 30 & May 14). ...