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FDA Clears Revolutionary AI Tool for Early Breast Cancer Risk Prediction

FDA Clears Revolutionary AI Tool for Early Breast Cancer Risk Prediction

Jun 02, 2025
Breast Cancer Research Foundation

The FDA has granted De Novo authorization to Clairity Breast, the first AI-powered platform that predicts a woman's risk of developing breast cancer over the next five years using only a standard mammogram, paving the way for more personalized and equitable breast cancer prevention and care.

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