FDA Clears Clairity’s AI Tool for Breast Cancer Risk Prediction

Clairity, a Boston-based startup, has received de novo FDA clearance for Clairity Breast, the first AI tool to predict a person’s five-year breast cancer risk using routine mammograms. Unlike existing AI tools focused on cancer detection, Clairity Breast estimates future risk, offering a new layer of insight for early intervention.

Trained on a diverse patient population, the tool was developed using Hologic’s 2D screening mammography systems to improve accuracy across demographics.

Clairity plans to launch the feature by the end of the year.

With 2.3 million breast cancer cases diagnosed globally in 2022, and many patients lacking a family history, Clairity aims to improve personalized screening beyond traditional risk models based only on age or genetics.

11-06-2025