FDA Clears Updated Version of 3D Mammography Algorithm from Lunit

The Food and Drug Administration (FDA) has granted 510(k) clearance for version 1.2 of Lunit’s 3D mammography algorithm.

Emphasizing efficiency and flexibility with the integration of AI for mammogram reads, the company noted key features of the updated algorithm.

The 3D mammography algorithm enables comparison of a current mammogram with up to two prior mammography exams, according to Lunit. Recognizing challenges with increased false positives that have been noted with AI, Lunit says the updated algorithm provides three selectable thresholds that allow clinicians to navigate tradeoffs with sensitivity and specificity.

Lunit added that the algorithm provides access to volumetric breast density measurements with the Volpara Scorecard, which has been validated for use with version 8 of the Tyrer-Cuzick model for estimating 10-year and lifetime risks for breast cancer.