Nearly a year after receiving the 2nd non-approvable letter for its flagship LuViva cervical scanner, Guided Therapeutics filed a new PMA last week with high hopes. The FDA has 180 days to respond to the company’s new application.
"We believe that our PMA amendment addresses the remaining questions the agency had about our application," CEO Gene Cartwright said in prepared remarks. "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 new run at FDA approval comes after a "productive" meeting with the FDA in May, which Guided Therapeutics had requested after a September 2013 rejection.
The Georgia-based device maker was 1st rebuffed in January 2013 when the FDA refused its original PMA bid, asking that the company provide additional data on updates to the device and make some changes to clinical trial parameters. Guided Therapeutics made some progress with regulators and in July 2013 announced that it had an FDA-approved path forward to a PMA for LuViva, a non-invasive scanning system designed to detect disease that leads to cervical cancer.
Guided Therapeutics revealed last September that FDA regulators were still not satisfied with its amended application. The company had been working for months with the bureau to revamp its once-rejected PMA bid, but the FDA raised new questions about LuViva. The new queries add to more than 100 questions already answered about the scanning technology, Guided Therapeutics said at the time.
The LuViva system is already approved for markets in Europe, Mexico, Canada, Singapore and others. Guided Therapeutics is also looking to expand in the Middle East, Asia and Latin America.