FDA Clears First AI Tool for 5-Year Breast Cancer Risk Prediction from Mammograms
May 31, 2025
Clairity Breast becomes the first FDA-authorized AI software to predict five-year breast cancer risk using routine mammography images.
Key Details
- FDA grants de novo authorization to Clairity Breast, developed by Boston-based Clairity.
- The AI tool analyzes mammogram images for subtle features correlated with future cancer risk.
- Unlike traditional models, Clairity Breast does not require age or genetic data.
- The system was trained on millions of mammogram images linked to five-year outcomes.
- Clairity Breast delivers validated risk scores to radiologists through standard clinical systems.
- Commercial launch is targeted for the end of 2025.
Why It Matters
This breakthrough FDA authorization marks a new era in preventive oncology by enabling earlier risk identification using only imaging, potentially improving precision prevention and patient outcomes in breast cancer care.