FDA clears iCAD's ProFound AI for DBT

By AuntMinnie.com staff writers

March 16, 2021 -- The U.S. Food and Drug Administration (FDA) has cleared computer-aided detection (CAD) software developer iCAD's ProFound artificial intelligence (AI) version 3.0 for digital breast tomosynthesis (DBT).

The updated software improves specificity by 10%, sensitivity by 1%, and processing speed on its PowerLook platform by 40%, the company said.

In 2018, ProFound AI was the first 3D tomosynthesis software to be cleared by the FDA, according to iCAD. The new version was developed on more than 5 million images from 30,000 cases, including 8,000 biopsy-confirmed cancers; it was validated on 1 million images from 3,500 cases that included 1,200 biopsy-confirmed cancers, the company said.

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