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FDA grants 510(k) clearance for Lunit AI solution to detect breast cancer

November 19, 2021

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Lunit’s artificial intelligence (AI) software, Lunit INSIGHT MMG, for detecting breast cancer.

Developed using Lunit’s deep learning technology, the new AI solution accurately analyses mammography images to detect lesions that could indicate breast cancer.

It also provides the location information for any detected lesions in the form of outlines and heatmaps.

An abnormality score is generated for each breast side that reflects Lunit INSIGHT MMG’s calculation of the presence of detected breast cancer.