What is the story about?
What's Happening?
Guided Therapeutics, Inc. announced the completion of patient enrollment for its US FDA clinical trial of the LuViva Advanced Cervical Scan, a non-invasive device for cervical cancer detection. The trial enrolled approximately 430 patients across four clinics, meeting the company's 2025 objective. The study aims to analyze biopsy samples and perform statistical analysis to determine the effectiveness of the LuViva device. No adverse events have been reported, supporting the FDA's designation of LuViva as a non-significant risk device. The clinical report is expected to be filed with the FDA later this year.
Why It's Important?
The completion of this clinical trial marks a significant milestone for Guided Therapeutics in advancing cervical cancer detection technology. The LuViva device offers a rapid and painless testing method, potentially improving early detection and patient outcomes. Successful results could lead to FDA approval, expanding access to innovative diagnostic tools and enhancing cervical cancer screening protocols. This development is crucial for the medical device industry, as it underscores the importance of non-invasive technologies in improving healthcare delivery.
What's Next?
Guided Therapeutics will proceed with data analysis and external review of biopsy samples, followed by statistical analysis as per the study protocol. The company anticipates filing the clinical report with the FDA later this year, which could lead to regulatory approval and commercialization of the LuViva device. Stakeholders, including healthcare providers and patients, are likely to monitor the outcomes closely, as they could influence future cervical cancer screening practices and technology adoption.
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