Guided Therapeutics has filed an amendment to its premarket approval (PMA) application with the US Food and Drug Administration (FDA) for the LuViva advanced cervical scan following its face-to-face meeting with the agency.
The company had a face-to-face meeting with the FDA in May 2014 to address the questions raised by the agency in its not-approvable letter on 6 September, 2013.
Guided Therapeutics CEO Gene Cartwright said: "We believe that our PMA amendment addresses the remaining questions the agency had about our application.
"While we await a decision on the U.S. market, we continue to see momentum building in the larger international market where we are working to increase pilot studies with LuViva, drive sales and build market share."
The FDA will respond to the amendment in 180 days from the day of filing the PMA amendment.
Guided Therapeutics has already received approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority.
LuViva, a technologically advanced diagnostic device, scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue.
The device is intended for use on women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases, involves taking a biopsy of the cervix.
It is used in conjunction with the LuViva Cervical Guide single-use patient interface and calibration disposable. The device does not require laboratory analysis or a tissue sample and provides results immediately.