What's Happening?
Guided Therapeutics, Inc. has announced the completion of patient enrollment for its U.S. FDA clinical trial of the LuViva Advanced Cervical Scan, a device for cervical cancer detection. The trial, involving approximately 430 patients across four clinics, aims to analyze biopsy samples and perform statistical evaluations. The LuViva device, which uses biophotonic technology, has been designated as a non-significant risk device by the FDA, with no adverse events reported during the trial.
Why It's Important?
The completion of this trial marks a significant step for Guided Therapeutics in advancing its cervical cancer detection technology. The LuViva device could potentially offer a rapid, non-invasive alternative to traditional screening methods, improving early detection and patient outcomes. Successful trial results may lead to FDA approval, impacting the medical device industry and providing a new tool for healthcare providers in the fight against cervical cancer.
What's Next?
Following the data analysis phase, Guided Therapeutics plans to submit the clinical report to the FDA later this year. If approved, the LuViva device could enter the U.S. market, potentially transforming cervical cancer screening practices. The company may also explore further applications of its biophotonic technology in other areas of disease detection.
