Guided Therapeutics is planning to submit an amendment to its premarket approval (PMA) application for the LuViva Advanced Cervical Scan following "productive" discussions with officials of the US Food and Drug Administration.
The filing will include responses to questions raised in the agency’s 6 September 2013 not-approvable letter, according to the company.
Guided Therapeutics chief executive officer Gene Cartwright said, "We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days."
The FDA will have 180 days to respond to the company’s submission.
LuViva is a diagnostic device that scans the cervix with light and employs spectroscopy to measure how light interacts with the cervical tissue.
The device is currently used in conjunction with the LuViva Cervical Guide single-use patient interface and calibration disposable.
While Guided Therapeutics has regulatory approval to sell LuViva in Europe, Canada and Singapore, it has filed for approval in Mexico.