FDA OK's iCAD tomosynthesis software

Computer-aided detection (CAD) developer iCAD said its PowerLook Tomo Detection software has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA).

PowerLook Tomo Detection is concurrent-read CAD software for digital breast tomosynthesis (DBT). It automatically analyzes each tomosynthesis plane and identifies suspicious areas, which are blended onto a 2D synthetic image to provide radiologists with a single enhanced image, the firm said.

PowerLook Tomo Detection is currently available on GE Healthcare DBT systems. It received the CE Mark and Health Canada approval in 2016 and is currently being used by multiple breast imaging centers in Europe, according to iCAD.

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