FDA Approves First Predictive AI for Breast Cancer Risk
The FDA has approved the first AI tool designed to predict a patient's five-year breast cancer risk directly from a mammogram. The tool, named the Clarity Breast Score, is now deployed at Beth Israel Deaconess Medical Center and represents a shift from reactive diagnostic AI to proactive, predictive healthcare.
- The AI model, developed by Boston-based Clairity, Inc., analyzes subtle patterns in mammogram images that are invisible to the human eye to calculate a five-year risk score. This approach is a significant departure from traditional risk models that rely on factors like age and family history. - The FDA granted "De Novo" authorization, a classification for first-of-its-kind medical devices, positioning the tool as a new standard in the breast cancer prediction market. The tool is intended to be used by radiologists after their standard interpretation of the mammogram is complete. - The AI was trained on millions of mammograms and validated on over 77,000 images from diverse populations across five different screening centers, with outcomes tracked over five years. This diverse dataset is a key differentiator from older models, which were often based on less diverse populations. - Unlike diagnostic AI that identifies existing cancers, this tool is prognostic, predicting the likelihood of future cancer development in a mammogram that appears normal. This allows for a shift towards proactive, personalized screening and prevention strategies for high-risk individuals. - Studies have shown that similar image-based AI models can outperform traditional risk assessment methods, such as the Tyrer-Cuzick model, in accurately predicting breast cancer risk. This increased accuracy can help identify high-risk women who may benefit from supplemental screenings like MRI or more frequent mammograms. - The technology aims to address a significant gap in current screening protocols, as approximately 85% of women diagnosed with breast cancer have no family history of the disease, and nearly half have no identifiable risk factors. - The founder of Clairity is Dr. Constance "Connie" Lehman, a professor at Harvard Medical School and a breast imaging specialist at Massachusetts General Hospital, who developed the technology to move from age-based to more effective risk-based screening. - Clairity plans a commercial launch of the product, branded as Clairity Breast, through leading health systems by the end of 2025.
