FDA Agrees to Reschedule Meeting Over LuViva Device With Guided Therapeutics
The FDA has granted Guided Therapeutics’ request to set a new meeting date of Nov. 30, 2015, to review the company’s plan to submit an approvable application for the LuViva Advanced Cervical Scan.
The request came in an effort to accommodate doctors’ schedules, the company said.
LuViva aims to detect cervical pre-cancer without taking a tissue sample and providing an immediate result. It uses spectroscopy to measure how light interacts with cervical tissue.
The device is approved in Europe, Canada and Mexico, and is currently available to women in 20 countries. — Michael Cipriano