Guided Therapeutics has answered all questions raised by the US Food and Drug Administration (FDA) related to the company's premarket approval (PMA) application for the LuViva Advanced Cervical Scan.
LuViva Cervical Scan is a non-invasive device which uses the company’s patented biophotonic technology to detect disease at the cellular level.
The patented biophotonic technology distinguishes normal and diseased tissue by detecting biochemical and morphological changes at the cellular level.
Guided Therapeutics president and CEO Mark Faupel said they are pleased to provide the FDA with the additional information the agency requested and within the time period required to maintain the PMA application under active review.
"We continue to make progress with our planned international launch and have orders in place with qualified distributors for demonstration and clinical units for Europe and Asia," Faupel said.