A Breakthrough in Breast Cancer Prevention: FDA Clears First AI Tool to Predict Risk from a Mammogram

How Clairity Breast is shaping the future of proactive, personalized breast cancer care

Each year, more than 2.3 million women worldwide are diagnosed with breast cancer—including over 370,000 in the United States alone. Despite decades of progress, far too many women are still diagnosed after the disease has already taken hold, including many with no family history or known risk factors.

Now, a revolutionary new platform is poised to change that.

The U.S. Food and Drug Administration (FDA) has granted De Novo authorization to Clairity Breast, the first-ever AI-powered platform that predicts a woman’s risk of developing breast cancer over the next five years—using only a standard mammogram. De Novo authorization is especially meaningful as it marks the very first platform of its kind.

With support from the Breast Cancer Research Foundation (BCRF), Clairity, Inc. is poised to launch the first predictive imaging model in breast cancer. This historic milestone is a major advance in prevention, equity, and personalized care.

What makes Clairity Breast different

Unlike current risk models—which depend on factors like age, family history, or self-reported questionnaires—Clairity Breast analyzes the mammogram itself. The platform uses advanced artificial intelligence to detect subtle imaging patterns in breast tissue that correlate with future cancer development, even if the mammogram appears normal to the human eye.

The result: a validated five-year risk score that can guide personalized follow-up care before any sign of disease appears.

“Clairity’s FDA authorization is a turning point for more women to access the scientific advances of AI-driven cancer risk prediction,” said Dr. Larry Norton, founding scientific director of BCRF. “Now, we can ensure more women get the right care at the right time.”

Why it matters

Currently, most screening guidelines are based on age. But recent data analyzed by Clairity shows that many women in their 40s have breast cancer risk levels similar to women in their 50s and 60s. In a study of over 30,000 mammograms:

• 37 percent of women in their 40s were found to be at intermediate risk
• 16 percent of women in their 40s were found to be at high risk
• These risk levels matched or exceeded those of older women typically targeted by current screening guidelines

These findings support a more individualized, risk-based screening approach, which Clairity Breast now makes possible. This has been a major focus of BCRF’s efforts to improving early detection in younger women, especially when there is an opportunity to intercept the disease before it takes root.

A more equitable future

BCRF is especially encouraged by Clairity Breast’s potential to close critical gaps in care. Traditional risk models often miss women who don’t have a family history of breast cancer—yet 85 percent of women diagnosed with the disease fall into this group. Others may live in healthcare deserts where access to advanced imaging is limited. Additionally, traditional risk models, built on data from predominantly European Caucasian women, have not generalized well to women of diverse racial and ethnic backgrounds.

Clairity Breast changes the equation by:

• Requiring only a standard 2D mammogram
• Integrating seamlessly into existing clinical workflows
• Removing reliance on demographic, genetic, or self-reported data
• Ensuring proportional representation of racial and ethnic groups in its model

“A deeply important aspect of Clairity Breast is that it was developed with an intentional focus to reduce disparities by ensuring accurate representation,” said BCRF Chief Scientific Officer Dr. Dorraya El-Ashry. “This means more women, in more places, can benefit from early, accurate risk prediction—a key goal in BCRF’s mission to expand equity in cancer care.”

From detection to prevention

For decades, mammograms have been a cornerstone of early breast cancer detection. Clairity Breast takes that legacy further—transforming a diagnostic tool into a predictive one.

A high-risk score as determined by the AI algorithm can prompt:

• Supplemental imaging like MRI
• Earlier and more frequent screenings
• Preventive interventions such as medication, lifestyle changes, or genetic counseling

Just as important, women at lower risk may be spared unnecessary tests or anxiety. This approach empowers healthcare providers to tailor care more effectively, improving outcomes while reducing costs and overtreatment.

Launching in 2025—and what’s next

Clairity, Inc. plans to launch Clairity Breast commercially in late 2025, with availability through hospitals, imaging centers, and digital health channels. Initially offered through a self-pay model, the company is working closely with insurance providers and Medicare to pursue coverage and reimbursement.

BCRF encourages women to speak with their healthcare providers about risk-based screening and to advocate with insurers for access to this groundbreaking tool.

“For more than 60 years, mammograms have saved lives by detecting early-stage cancers. Now, advancements in AI and computer vision can uncover hidden clues in the mammograms – invisible to the human eye – to help predict future risk,” said Dr. Connie Lehman, founder of Clairity, who is also a breast imaging specialist at Mass General Brigham. “By delivering validated, equitable risk assessments, we can help expand access to life-saving early detection and prevention for women everywhere.”

BCRF’s commitment to innovation

“At the Breast Cancer Research Foundation, we believe research is the key to saving lives,” said BCRF President and CEO Donna McKay. “Clairity Breast reflects the power of visionary science paired with real-world impact—two pillars that define our work.”

We will continue to invest in innovation, advocate for access, and ensure that every woman has the tools she needs to take control of her health.