AI-Based Breast Cancer Risk Software Gets FDA Breakthrough Device Designation

tim.hodson

Wed, 07/30/2025 – 10:27

July 29, 2025 — A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman’s personalized five-year risk of developing breast cancer has received Breakthrough Device designation from the Food and Drug Administration (FDA). Developed by researchers at Washington University School of Medicine in St. Louis, the software has been licensed to Prognosia Inc., a WashU startup company.
The system analyzes mammo…

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