About 85% of breast cancers occur in women with no family history of the disease. That single statistic is the clearest argument for why risk assessment tools need to go beyond family history, and it’s the clinical rationale behind a new partnership that could reach millions of women who currently have no reason to think they’re at risk.
Everlywell announced on October 1 the nationwide commercial launch of Clairity Breast, an FDA-authorized AI software that estimates a woman’s five-year risk of developing breast cancer using images from a standard screening mammogram. The product is now available through Everlywell’s consumer platform, with ordering and review handled by licensed providers in Everlywell’s affiliated clinician network.
What Clairity Breast actually does
Clairity Breast does not screen for cancer or detect existing tumors. It analyzes patterns in mammogram images, patterns that are not visible to radiologists, to estimate the probability that a woman will develop breast cancer within the next five years. The output gives women and their clinicians a new data point for planning screening frequency and risk-reduction strategies.
The software received FDA De Novo authorization in May 2025, making it the first AI-based tool cleared for this specific purpose. It has since been included in the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis. Updated NCCN guidelines published in 2026 now recognize AI-based mammogram risk assessment as an option for identifying women at increased risk, starting at age 35. Prior to this Everlywell partnership, access was limited to a small number of health systems including Beth Israel Deaconess Medical Center in Massachusetts and Invision Sally Jobe in Colorado.
How the Everlywell platform delivers it
Women with a qualifying screening mammogram from the past 12 months can access the assessment through the Everlywell platform. The process includes review and ordering by a licensed provider, followed by results released with next steps based on national guidelines. Women can then share their results directly with their own physician to inform a personalized screening or risk-reduction plan. Everlywell’s clinical team is also available to answer questions about individual results.
Clairity Breast joins a growing portfolio of cancer screening products on the platform, which already includes at-home colon cancer screening, an HPV self-collection kit for cervical cancer screening, and access to multi-cancer early detection testing.
The clinical case for broader access
The value of a tool like this sits in the gap between current practice and what’s possible. Standard risk assessment relies heavily on family history and genetic markers like BRCA1 and BRCA2. But most women who develop breast cancer don’t carry those markers and have no affected relatives. Their mammograms are read for findings today, not for risk tomorrow.
Clairity Breast was validated across more than 77,000 screening mammograms at five U.S. sites for FDA authorization, and has since been validated in more than 120,000 mammograms across 10 U.S. facilities. That’s a meaningful evidence base for a relatively new category of tool.
“The information we need to understand a woman’s breast cancer risk has been in her mammogram all along, we just haven’t been able to interpret it until Clairity Breast,” said Dr. Connie Lehman, founder and CEO of Clairity and professor of radiology at Harvard Medical School.
Why this partnership matters beyond the product
The Everlywell and Clairity partnership also reflects a broader shift in how specialized clinical tools reach patients. Health system rollouts are slow. Consumer platforms with existing clinical infrastructure can move faster, and Everlywell has the reach to make that count. The company reports delivering nearly one billion personalized health insights and serving more than 60 million people since its founding.
Both companies are female-founded and female-led, a detail worth noting in a space where women’s health has historically been underfunded and under-researched. Julia Cheek built Everlywell; Dr. Lehman, a radiologist and researcher, built Clairity. The product they’ve brought to market together addresses a real gap in preventive care, and it does so using infrastructure that already exists in every qualifying mammogram a woman gets.
Pricing details were not disclosed at launch. The assessment is available now at everlywell.com.