FDA Approves AI Program for Breast Cancer Risk Prediction

The U.S. Food and Drug Administration (FDA) has granted de novo authorization to Clairity Breast, the first artificial intelligence (AI) program designed to predict breast cancer risk from screening mammograms. The AI analyzes mammograms for subtle features linked to future cancer risk, generating a 5-year risk score validated across over 77,000 mammograms.
Dr. Larry Norton, a breast cancer specialist at Memorial Sloan Kettering Cancer Center, expressed enthusiasm for the technology, stating it could "help people" and "improve patient adherence" to screening recommendations. The system can immediately inform decisions about additional imaging, such as breast MRI, and aid in personalized, risk-based screening strategies.
Robert Smith, PhD, of the American Cancer Society, highlighted the potential of integrating AI models to better identify women at higher risk and improve early detection and prevention strategies. In a study leading to FDA authorization, Clairity Breast outperformed traditional risk models, detecting 8.6 cancers per 1,000 patients compared to 4.4 and 3.8 with other models.
Dr. Norton emphasized AI's broad applications in clinical practice, from mammogram interpretation to patient communication, calling it a transformative tool in modern medicine. The FDA authorization marks a significant step toward leveraging AI to enhance breast cancer outcomes and advance personalized healthcare.

Published: 6/2/2025