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| The FDA has more questions over Guided Therapeutics' LuViva device.--Courtesy of Guided Therapeutics |
After twice failing to sway U.S. regulators, Georgia's Guided Therapeutics ($GTHP) is heading to the FDA once more with its cervical scanning device, hoping to finally win approval for the long-delayed technology.
In its latest rejection of Guided Therapeutics' LuViva, handed down in September, the agency said it wanted to see new analysis of the device's clinical data and more information on disinfection of the scanner and its optics. Last week, the company sat down with regulators to clarify their requirements, and CEO Gene Cartwright said he believes the parties reached an understanding.
"The meeting was constructive and we were able to put forward our logic and arguments and engage in a detailed discussion with the FDA," Cartwright said in a statement. "We will incorporate our responses and FDA feedback into our formal response, which we plan to file within the next 45 days."
That story may sound familiar. After Guided Therapeutics endured its first FDA rebuff in 2012, the company held a "productive" meeting with the FDA that identified a path to approval, Cartwright said at the time. A year later, LuViva notched its second rejection.
Aside from its efforts on the U.S. regulatory front, Guided Therapeutics is in the midst of a commercial rollout of the device, which is CE marked for overseas sales.
LuViva is a diagnostic device that uses spectroscopy to analyze cervical tissue, identifying precancerous cells without the need for lab analysis or biopsy, the company said.
- read the statement