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Medical Devices / Submissions and Approvals

FDA Clears ScreenPoint Medical’s AI System for Reading Mammograms

Nov. 28, 2018

The FDA has given 510(k) clearance to ScreenPoint Medical’s Transpara software, an artificial intelligence application designed to support radiologists in the reading of screening mammograms.

Transpara has already received the CE Mark for use with mammography and digital breast tomosynthesis images and the application has been installed in European breast imaging centers.

The AI application, which is used for detecting breast cancer through suspicious abnormalities, also helps radiologists decide whether to follow up on the abnormalities. It automatically detects soft-tissue and calcification lesions and combines its findings into a single cancer suspiciousness score.

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