Dr. Connie Lehman, founder of Clairity and breast imaging specialist at Massachusetts Brigham Hospital, developed the CLAIRITY BREAST AI platform. Classified as Class II medical software (SaMD), it is the first AI platform approved by the FDA to predict breast cancer risk.
Using supervised learning algorithms and mammography images, CLAIRITY BREAST estimates a woman’s risk of developing breast cancer within five years. Its key advantage lies in identifying high-risk women and recommending advanced screenings such as MRI.
Lehman highlights that this innovation shifts the focus from early detection to proactive risk assessment and prevention. The platform’s diverse training dataset—covering geography, race, and ethnicity—enhances accuracy. This represents a historic milestone in women’s health.
Dr. Connie Lehman highlights that breast cancer risk is not a new concept, but the novelty lies in having a risk model that can identify women without family history who are still at high risk—cases overlooked by traditional models. She expresses excitement about shifting from “protection and detection” to “prediction,” a change that could significantly expand the impact of screening and prevention.
She notes that this milestone was long overdue and credits the Clairity team, consortium members, and global collaborators for advancing approaches that improve risk reduction and screening. This collective effort enables better risk assessment, improved screening for high-risk women, and stronger preventive strategies against breast cancer.
