FDA Authorizes First AI-Powered Breast Cancer Risk Prediction Tool

The Food and Drug Administration (FDA) has granted de novo authorization to Clairity Breast, the first artificial intelligence tool designed to predict patients' five-year breast cancer risk from routine mammograms. Developed by Boston-based startup Clairity, this groundbreaking technology marks a significant shift in breast cancer risk assessment and early detection strategies.

Revolutionary Approach to Breast Cancer Risk Prediction

Clairity Breast represents a departure from traditional computer-aided detection systems for breast cancer, which have been in use since 1998. While existing tools focus on detecting present cancer, Clairity's AI-powered system analyzes mammogram images to predict future risk over a five-year period.

Dr. Connie Lehman, founder of Clairity and a diagnostic radiologist at Mass General Brigham, explained the innovation: "We're doing something radically different than what I've done my whole career in the area of computer-aided detection and diagnosis of breast cancer. It's extracting subtle cues in the mammogram that the human eye can't see, the human brain can't process."

This novel approach has the potential to identify high-risk individuals who may have been overlooked by current risk models, which primarily consider factors such as age and family history. Notably, most people diagnosed with breast cancer have no family history of the disease, underscoring the importance of more comprehensive risk assessment tools.

Development and Implementation

Clairity Breast was developed using Hologic's 2D screening mammography systems and will be integrated into routine mammogram procedures. The company has emphasized the importance of diverse patient data in training its AI models, addressing historical biases in breast cancer risk prediction models that were predominantly based on data from white women.

The startup plans a phased rollout of the predictive tool, beginning with select centers and expanding access later this year. To spearhead the market launch, Clairity hired Jeffrey Luber as CEO in 2024. Luber brings valuable experience from his former roles as CEO of testing firms Binx Health and Exact Sciences.

Financial support for the project includes a $1 million investment from the Breast Cancer Research Foundation, received in January 2025.

As breast cancer remains a global health concern, with approximately 2.3 million new cases diagnosed worldwide in 2022 according to the World Health Organization, Clairity Breast has the potential to significantly impact early detection and risk management strategies in the fight against this pervasive disease.