Guided Therapeutics to Submit PMA Amendment for LuViva Cervical Scan
Norcross, Ga., devicemaker Guided Therapeutics said Wednesday it is readying an amendment to its premarket approval application for the LuViva Advanced Cervical Scan after “productive” discussions with FDA officials last week.
The amendment will respond to questions raised by the agency in a Sept. 6, 2013, not-approvable letter, the company said.
“The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA,” reported CEO Gene Cartwright. “We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days.”
Once submitted, the FDA will have 180 days to decide whether to approve the amended PMA. Guided Therapeutics said it expects further dialog with the agency as the review process moves forward.
According to Guided Therapeutics, LuViva scans the cervix with light, using spectroscopy to measure the light’s interaction with cervical tissue to identify precancerous cells that may be below the surface of the cervix or misdiagnosed as benign. Because the results are immediate, patients are able to avoid costly and painful testing.
LuViva is currently available in Europe, Canada and Singapore. The company has filed for approval in Mexico. — Kellen Owings
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