The first clinical patient has received a Clairity Breast cancer risk score, marking a historic milestone in women’s health and breast cancer prevention.
Clairity Breast, developed by Boston-based Clairity Inc., is the first FDA-authorized, image-based artificial intelligence (AI) tool designed to predict a woman’s future risk of breast cancer. The technology derives the risk score directly and exclusively from a mammogram, transforming a standard diagnostic tool into a predictive instrument for preventive care.
Authorized by the U.S. Food and Drug Administration via the De Novo pathway, Clairity Breast allows health care providers to identify women at elevated risk years before a potential diagnosis, using information already contained in routine mammograms.
Massachusetts Governor Maura Healey praised the innovation, saying, “Massachusetts has long been a leader in health care, tech, and innovation, and we are committed to advancing solutions that improve people’s health and save lives. It’s inspiring to see Clairity using AI to help women understand their breast cancer risk earlier. Congratulations to Dr. Lehman and her team on this incredible milestone.”
Traditionally, breast cancer risk assessment has relied on family history or known genetic mutations. Yet most women diagnosed with breast cancer have neither, often leaving them unaware of their elevated risk until after a diagnosis.
“For decades, screening mammograms have been used solely to detect existing breast cancer,” said Dr. Connie Lehman, founder and CEO of Clairity and Professor of Radiology at Harvard Medical School. “Now, we can use the same mammogram to identify women who are at higher risk for developing breast cancer in the future—women who are often missed by traditional risk assessment methods.”
Dr. Elizabeth Mittendorf, Chief of the Division of Breast Surgery at Beth Israel Deaconess Medical Center, called the technology a “game changer.” She explained, “When we know a woman is at increased risk—whether due to inherited biology, environmental factors, or both—we can guide her toward more effective screening and prevention strategies.”
Clairity Breast is designed for real-world clinical integration, fitting directly into existing imaging and reporting systems. Risk results are automatically generated from screening mammograms, returned in a clear, interpretable format, and support shared decision-making between patients and providers.
“Today’s first clinical patient marks the beginning of a new chapter in women’s health—one where more women can understand their risk early and receive care tailored to their needs,” said Donna McKay, president and CEO of the Breast Cancer Research Foundation. “It’s an era in which patients gain a glimpse into their future and the tools to change it.”
