The U.S. Food and Drug Administration (FDA) has granted De Novo approval for CLAIRITY BREAST, an AI-powered tool developed by Clairity, Inc., also known as Allix5. This CLAIRITY BREAST is an artificial intelligence (AI) tool that analyzes standard mammograms to assess the 5-year risk of breast cancer. Clairity proposes to expand AI technology in leading healthcare systems by 2025. This approval shows a significant development in precision healthcare medicine.
CLAIRITY BREAST is designed to evaluate the risk of breast cancer through pixel-level image analysis. It is validated using over 77,000 mammograms. All the mammograms are collected from 5 different screening centres after being trained on millions of images. The results from the 5-year outcomes data revealed their accuracy across a variety of facility types and populations.
Worldwide, approximately 2.3 million new cases of breast cancer are diagnosed annually, including more than 370,000 of those cases occurring in U.S. women. Accurate cancer risk assessment supports life-saving measures such as early identification and prevention. Existing available tools are mostly based on the age and history of the patient’s family. However, nearly half of breast cancer patients have no identifiable risk factors, whereas 85% of patients have no family history of this cancer. Hence, more inclusive and accurate risk prediction tools are necessary for early prevention and identification of breast cancer. Currently available models frequently do not work well for women from a variety of racial and ethnic backgrounds. These models are primarily based on data from European Caucasian women. This approval makes CLAIRITY BREAST a first-in-class platform, setting a new standard in the $63 billion breast cancer prediction market for risk-based screening, personalized care, and prevention.
“CLAIRITY BREAST is a breakthrough because it can predict future risks from patterns in breast tissue, even when a mammogram looks normal. It’s built to work easily with current systems, helping doctors prevent cancer more precisely, reduce late diagnosis, and save lives,” said Jeff Luber, CEO of Clairity.
Dr. Connie Lehman, Founder of Clairity, Breast imaging expert at Mass General Brigham, said, “Mammograms have been saving lives by detecting breast cancer early for over 60 years. Now, new technology using computer vision and AI can detect minute changes in mammograms that people cannot see, helping to predict future cancer risk.”
Larry Norton from the Breast Cancer Research Foundation added, “Clairity’s FDA approval is a big step toward giving more women access to advanced, AI-based risk prediction, especially since traditional models often miss many who later develop breast cancer.”
Dr. Robert Smith from the American Cancer Society explained that using AI to assess individual risk can help doctors better identify women who need extra screening, such as an MRI, thereby enhancing early prevention and detection.
Clairity’s first-in-platform is designed to seamlessly integrate with existing clinical workflows, enabling it to perform breast cancer risk assessment and prevention at scale efficiently. Its innovative approach enhances precision care, helping clinicians identify at-risk patients earlier and supporting timely, personalized screening and intervention strategies.
Reference: Businesswire. ADDING MULTIMEDIA Clairity Becomes the First FDA-Authorized AI Platform for Breast Cancer Prediction – Historic Milestone for Women’s Health. Published Jun 2, 2025. Accessed Jun 9, 2025. ADDING MULTIMEDIA Clairity Becomes the First FDA-Authorized AI Platform for Breast Cancer Prediction – Historic Milestone for Women’s Health
