Feb.23, 2026 — The first clinical patient received a Clairity Breast cancer risk score, marking a historic milestone in women’s health.
Clairity Breast, a product of Clairity Inc., is the first FDA-authorized, image-based artificial intelligence tool designed to assess a woman’s future risk of breast cancer. This AI technology derives the score directly and exclusively from a woman’s mammogram, transforming a diagnostic tool into a predictive one.
Authorized by the U.S. Food and Drug Administration through the De Novo pathway, Clairity Breast represents a new class of medical technology. For the first time, health care providers can use information already contained within a routine screening mammogram to identify women at increased risk for future breast cancer, years before a diagnosis might otherwise occur.
Massachusetts Gov. Maura Healey applauded this groundbreaking innovation: “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 great to see Clairity, a Boston-based company, using AI to help more women understand their risk of breast cancer earlier. Congratulations to Dr. Lehman and her team on this incredible milestone."
Until now, breast cancer risk assessment has relied largely on family history and inherited genetic mutations. But the majority of women diagnosed with breast cancer have no known genetic mutation and no family history of the disease. As a result, many women are surprised by their diagnosis and learn that they are at higher risk only after cancer has formed and is then finally discovered.
“For decades, screening mammograms have been used solely to detect breast cancer that is already present,” said Dr. Connie Lehman, founder and CEO of Clairity and Professor of Radiology at Harvard Medical School. “Now, we can use the screening mammogram for an additional and vital purpose – to identify women who have a higher risk for developing breast cancer in the future. These women, unfortunately, are often missed by traditional risk assessment methods.”
“This is a game changer to have Clairity Breast identify women at higher risk of breast cancer,” said Dr. Elizabeth Mittendorf, MD, PhD, Chief of the Division of Breast Surgery at Beth Israel Deaconess Medical Center. “When we know a woman is at increased risk either through inherited biology or environmental factors or a combination of the two, we can direct her to more effective cancer screening and cancer prevention pathways.”
Designed for real-world clinical environments, Clairity Breast integrates directly into existing imaging and reporting systems, allowing health care providers to order, review and document risk results within their established workflows. The five-year risk score is automatically generated from the screening mammogram and returned in a calibrated, interpretable format to support shared decision-making between health care providers and patients.
“Today’s first clinical patient marks the beginning of a new chapter in women’s health – one in which far more women can understand their risk earlier and benefit from care that is better matched to their individual needs,” said Donna McKay, president and CEO of the Breast Cancer Research Foundation. “An era in which patients are offered a peek into their future and are armed with the information to effectively change it.”
To learn more about Clairity, visit clairity.com.
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