Everlywell Expands U.S. Access to Clairity Breast AI Risk Assessment
Published in Artificial Intelligence, Personalized medicine, Scanners and Imaging, Tools.
Everlywell announced on October 1, 2026 that Clairity Breast is commercially available nationwide through its U.S. consumer platform. The AI software estimates a woman’s five-year breast cancer risk from a qualifying screening mammogram.
According to the announcement, patients can request an assessment using a suitable mammogram taken within the previous 12 months. The process includes ordering and review by a licensed provider, followed by release of results and guidance from Everlywell’s clinical network.
The underlying Allix5 device received FDA De Novo authorization on May 30, 2025. The FDA’s intended-use statement distinguishes future risk prediction from diagnosing or detecting an existing cancer. Its output is considered after the radiologist completes the mammogram interpretation, and it is not intended to replace clinical judgment or provide care recommendations by itself.
The news concerns expanded U.S. access, rather than a new regulatory authorization or Canadian availability. Risk information may support discussions about screening, but this launch announcement does not demonstrate improved survival or fewer cancer diagnoses.
Sources: Everlywell announcement, October 1, 2026; FDA Allix5 De Novo decision, May 30, 2025.