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ICAD receives US FDA approval for tomosynthesis technology

The U.S FDA granted premarket approval to iCAD Inc. for its PowerLook Tomo Detection, a computer-aided detection solution for digital breast 3D tomosynthesis.

A U.S clinical study suggested that the device significantly reduced reading time when reading 3D tomosynthesis exams.

The platform is available on GE healthcare's digital breast tomosynthesis systems. The product received CE Mark and Health Canada approval in 2016 and is being used by multiple high-volume breast imaging centers in Europe.