New Breast Cancer Risk Tool Expanded Nationwide
Everlywell now offers an AI-powered risk assessment tool to women with recent mammograms across the United States.
Updated on Oct. 1, 2026 in Cancer
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Everlywell has expanded national access to the FDA-approved Clairity Breast risk assessment tool. The service allows individuals to use mammogram images from the past 12 months to estimate their five-year risk for developing breast cancer.
Why it matters
This technology aims to improve early detection for sporadic breast cancers by identifying elevated risk levels. It provides a new option for individuals to assess their personal risk profile beyond standard mammogram reports.
The Clairity Breast tool is an FDA-cleared AI platform that analyzes mammogram imaging patterns correlated with future cancer development. The assessment provides risk scores that categorize individuals as average, intermediate, or high risk based on a 1.7% and 3% scoring threshold.
The players
Everlywell
A health company that provides at-home testing services and digital health tools to consumers.
Clairity Breast
An FDA-approved artificial intelligence platform that predicts five-year breast cancer risk based on imaging.
The details
The platform functions by retrieving a patient's existing mammogram image and processing it through an AI model designed to detect subtle imaging patterns. By analyzing these specific markers, the tool estimates the likelihood of a person developing breast cancer over the next five years. It is important to note that the test is designed for risk assessment rather than cancer detection and is not available to those with known genetic mutations or active cancer treatment.
Timeline
The FDA approved the Clairity Breast tool in 2025.
Individuals may use a mammogram taken within the past 12 months.
National access to the tool expanded on October 1, 2026.
Health Landscape
This service represents the practical, consumer-facing application of diagnostic tools cleared through the FDA's Software as a Medical Device (SaMD) authorization program. It follows a broader trend in medical technology aimed at moving beyond standard imaging reports toward personalized risk prediction.
The test costs $249 and is not covered by insurance, making cost an important factor in your decision to use it. If you are considering this assessment, it is worth discussing the results and their implications for your screening schedule with your doctor.
The takeaway
This tool helps categorize your potential risk for sporadic breast cancer over a five-year window. Discussing whether AI-based risk tools are appropriate for your specific medical history is a meaningful conversation to have with your physician.
Further reading
Learn more about advancements in screening and detection for Cancer.
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