More than 2.3 million women worldwide are diagnosed with breast cancer each year. In the United States alone, over 370,000 new cases are confirmed annually. Despite decades of progress in prevention and treatment, many women still learn of their diagnosis only after the disease is confirmed. Many of them have no family history or known risk factors.
A new AI platform may change that. The U.S. Food and Drug Administration (FDA) recently granted the first De Novo authorization to Clairity Breast. It is the first AI tool designed to predict a woman’s risk of developing breast cancer in the next five years using only a standard mammogram.
How Clairity Breast Stands Out
Traditional risk models rely on factors such as age, family history, or self‐report questionnaires. Clairity Breast takes a different approach. It analyzes the mammogram image itself. By using advanced AI, it detects subtle patterns in breast tissue that can signal future cancer, even when mammograms look normal to the human eye.
The platform generates a validated five-year risk score. This score can guide personalized follow-up care before any signs of disease appear.
“Clairity’s FDA authorization is a turning point for more women, giving them access to AI-driven science in cancer risk prediction,” said Dr. Larry Norton, Founding Scientific Director of the Breast Cancer Research Foundation (BCRF). “Now we can ensure more women get the right treatment at the right time.”
Why a New Approach Matters
Current screening guidelines are mostly based on age. But data from Clairity shows that many women in their 40s face risks similar to those in their 50s and 60s. In a study of over 30,000 mammograms:
37 percent of women in their 40s were at moderate risk
16 percent of women in their 40s were at high risk
These risk levels meet or exceed those of older women who are typically targeted by existing guidelines. The findings support a more personalized, risk-based approach to screening. With Clairity Breast, that approach becomes possible. The BCRF has focused on increasing early detection in younger women, where there is a chance to stop the disease before it takes hold.
Toward a More Equitable Future
Clairity Breast also addresses gaps in care for women without a family history. About 85 percent of women diagnosed with breast cancer fall into this group—yet traditional risk models often overlook them. Other barriers include limited access to advanced imaging in underserved areas. Moreover, most existing models are based on data from white European women and may not apply well to women of other racial or ethnic backgrounds.
Clairity Breast overcomes these issues by:
Requiring only a standard 2D mammogram
Integrating seamlessly into existing clinical workflows
Eliminating reliance on demographic, genetic, or self-reported data
Ensuring its AI model represents women of diverse racial and ethnic backgrounds
“An important aspect of Clairity Breast is that it was developed to reduce disparities by ensuring accurate representation,” said Dr. Dorraya El-Ashry, BCRF Chief Scientific Officer. “This means more women in more places can benefit from early, accurate risk predictions—a key goal of BCRF’s mission to expand equity in cancer care.”
From Detection to Prevention
For decades, mammograms have been central to early breast cancer detection. Clairity Breast advances that legacy by turning a diagnostic tool into a predictive one. A high-risk score from the AI algorithm may lead to:
Supplemental imaging such as MRI
Earlier and more frequent screenings
Preventive interventions, including medications, lifestyle changes, or genetic counseling
Equally important, women at low risk can avoid unnecessary testing and worry. This approach helps healthcare providers tailor care more effectively, improving outcomes while reducing costs and overtreatment.
Timeline for Launch and Future Steps
Clairity, Inc. plans to launch Clairity Breast in late 2025. The platform will be available through hospitals, imaging centers, and digital health channels. Initially, it will operate on a self-pay model. Clairity is also working with insurance companies and Medicare to secure coverage and reimbursement.
The BCRF encourages women to discuss risk-based screening with their healthcare providers. They also advocate with insurers for access to this groundbreaking tool.
“For more than 60 years, mammograms have saved lives by detecting early cancers,” said Dr. Connie Lehman, Clairity founder and breast imaging specialist at Brigham and Women’s Hospital. “Today, advances in AI and computer vision can reveal hidden clues in mammograms that are invisible to the human eye. By providing validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women around the world.”
BCRF’s Ongoing Commitment to Innovation
“At BCRF, we believe research is the key to saving lives,” said Donna McKay, BCRF President and CEO. “Clairity Breast embodies the power of visionary science and real-world impact—two pillars of our work. We will continue to invest in innovation, advocate for access, and ensure every woman has the tools she needs to take control of her health.”
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