Everlywell brings Clairity's FDA-authorized AI breast cancer risk tool to consumers nationwide
Tags AI / ML · Product
Everlywell launched Clairity Breast nationwide on its consumer platform, making the first FDA-authorized AI software that estimates a woman's five-year breast cancer risk from a routine screening mammogram directly available to consumers. Clairity Breast received FDA De Novo authorization in May 2025 and was validated in more than 77,000 screening mammograms at five US sites for authorization, and more than 120,000 across 10 facilities afterward. Updated 2026 NCCN guidelines include AI-based mammogram risk assessment as an option for identifying women at increased risk beginning at age 35. Patients with a qualifying mammogram from the past 12 months can access the assessment through Everlywell, with ordering and results reviewed by licensed providers.
Technical significance
Moving an FDA-authorized risk model from health systems to a direct-to-consumer platform changes who can act on the output, though the requirement for provider review keeps a clinician in the loop. Inclusion in NCCN guidelines gives the tool a reimbursement and clinical-workflow pathway that many AI diagnostics lack.