Guided Therapeutics Announces Plans for Advancing PMA Application
Guided Therapeutics Inc. announced that it has sent a “pre-submission” letter to the FDA, with plans for advancing the pre-market application for its LuViva Advanced Cervical Scan, a non-invasive cancer detection product.
The letter contains plans for a confirmatory study for the company to collect additional scans on patients. The FDA previously did not approve the device’s PMA application, citing a need for more patient data before signing off.
Guided Therapeutics, based in Georgia, has marketing approvals for LuViva from COFEPRIS in Mexico, Health Canada and the Singapore Health Sciences Authority, with regulatory approval to sell the product in Europe with the Edition 3 CE mark.
LuViva utilizes a technique called Biophotonics, which uses spectroscopy to identify chemical and structural indicators of pre-cancer that may be below the surface of the cervix. — Michael Cipriano