Everlywell puts an FDA-authorized AI breast-cancer risk score on sale to consumers nationwide

Everlywell, a consumer health-testing company, announced on 1 October “the nationwide launch and commercial availability of Clairity Breast on its consumer platform.” Clairity Breast is made by Clairity, a Boston company founded by Dr. Connie Lehman, a professor of radiology at Harvard Medical School.

The tool uses AI to estimate a woman's risk of breast cancer over the next five years from a standard screening mammogram, rather than from family history and questionnaires alone. To use it through Everlywell, a woman needs a qualifying screening mammogram from the past 12 months; a licensed provider orders the assessment, reviews it and releases the results.

The release says that in 2025 Clairity Breast “became the first AI-based tool to receive FDA De Novo authorization for predicting a woman's five-year breast cancer risk from a standard screening mammogram”, and that updated NCCN guidelines in 2026 introduced AI-based mammogram risk assessment as an option for identifying women at increased risk from age 35. The FDA's own record was not opened, so the first-of-its-kind claim is the companies'.

Lehman said: “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.” The release gives no price. Both companies are private.

• Confirmed Everlywell launched Clairity Breast nationwide on its consumer platform on 1 October; it needs a screening mammogram from the past 12 months and a licensed provider releases the results. Everlywell (Business Wire)
• Claimed In 2025 Clairity Breast became the first AI-based tool with FDA De Novo authorization to predict five-year breast cancer risk from a screening mammogram. Everlywell (Business Wire)