Vigilant Biosciences Receives FDA Breakthrough Device Designation

Posted: May 1, 2023
Edited by Dentaltown staff

LAKEWAY, Texas—Vigilant Biosciences, Inc. has received Breakthrough Device Designation from the Food and Drug Administration (FDA) for its point-of-care test to aid in the early detection of oral cancer.

The BeVigilant OraFusion Test provides a tool for oral cancer detection by determining the presence of certain biomarkers combined with artificial intelligence software for clinical risk factors. Early detection, as defined by detection in either Stage 1 or Stage 2, can lead to significantly improved outcomes with survival rates as high as 90%. The current oral cancer survival rate is only 50% due to delayed intervention.

The Breakthrough Devices Program was created to provide patients with more timely access to innovative medical devices by expediting their development, assessment, and review while preserving the statutory standards for premarket approval, 510(k) clearance, and DeNovo marketing authorization, according to the FDA.

For more information, visit vigilantbiosciences.com.

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