FDA Clears First AI Tool for Breast Cancer Risk Prediction, Paving Way for Personalized Screening

In a groundbreaking development for breast cancer prevention, the U.S. Food and Drug Administration (FDA) has granted de novo clearance to Clairity Breast, the first artificial intelligence (AI) tool designed to predict five-year breast cancer risk from routine screening mammograms. This innovative platform, developed by Boston-based startup Clairity, marks a significant shift in breast cancer screening and risk assessment strategies.

AI-Powered Risk Prediction: A New Frontier in Breast Cancer Screening

Clairity Breast utilizes advanced AI and computer vision technologies to analyze subtle imaging features in mammograms that correlate with future breast cancer risk. Unlike traditional risk models that rely on factors such as age and family history, this platform examines the mammogram itself, uncovering patterns invisible to the human eye.

Dr. Connie Lehman, founder of Clairity and a professor of radiology at Harvard Medical School, emphasized the transformative nature of this technology: "For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms—invisible to the human eye—to help predict future risk."

The AI model behind Clairity Breast was trained on millions of images and validated across more than 77,000 mammograms from five geographically distinct screening centers. This diverse dataset ensures the tool's applicability across various patient populations, addressing historical biases in breast cancer risk prediction models.

Implications for Personalized Breast Cancer Screening and Prevention

The introduction of Clairity Breast could significantly impact breast cancer screening protocols and prevention strategies. By providing a validated five-year risk score, the platform enables healthcare providers to offer more personalized follow-up care and identify women who may benefit from supplemental screening methods, such as MRI.

Robert A. Smith, Ph.D., senior vice president of early cancer detection science at the American Cancer Society, highlighted the importance of this development: "By integrating AI models that assess individual risk, we can better identify women at higher risk, and those who may benefit from supplemental screening methods, such as MRI, improving early detection and more effective prevention strategies."

Jeff Luber, CEO of Clairity, emphasized the platform's potential to revolutionize breast cancer prevention: "Clairity Breast is designed to fit seamlessly into the current clinical infrastructure to help providers scale precision prevention—with the goal of reducing late-stage diagnoses, lowering costs, and saving more lives."

With the FDA's clearance, Clairity plans to launch the risk prediction platform with leading health systems through 2025, potentially transforming breast cancer screening and prevention practices across the United States.