Everlywell puts Clairity’s FDA-authorized AI breast-risk score online nationwide

Everlywell said Thursday Clairity Breast is commercially available nationwide on its consumer platform, giving women with a qualifying recent screening mammogram access to the first FDA-authorized AI tool that estimates five-year breast cancer risk from that mammogram.

Most breast cancers still show up in women without a strong family history, and risk tools that need genetics or clinic visits leave a lot of people out. Putting an FDA-authorized mammogram AI risk score on a consumer platform with a clinician in the loop is a same-day test of whether preventive AI can reach women before the next screening appointment, not only inside a few academic hospitals.

On Thursday, 1 October 2026, Everlywell said Clairity Breast is commercially available nationwide on its consumer platform. The announcement is the Business Wire release “Everlywell Brings Clairity’s FDA-Authorized AI Breast Cancer Risk Assessment to Women Nationwide.” FinancialContent’s reprint of that wire stamps the item October 1, 2026, at 6:00 a.m. Eastern, and links the Business Wire page as the full release. The release opens on Breast Cancer Awareness Month. It says women across the United States can now get an FDA-authorized, AI-driven assessment of future breast cancer risk. A consumer platform, here, is Everlywell’s own site, where a person orders the test, rather than a hospital that already offers it. Those lines are Everlywell’s.

Clairity Breast, as the release describes it, is the first FDA-authorized AI-driven software that assesses a woman’s five-year risk of developing breast cancer from a routine screening mammogram. Five-year risk is an estimate of the chance she will develop breast cancer in the next five years. It is not a statement that cancer is already visible on the picture. The same release says Clairity Breast does not screen for or detect cancer. It estimates future risk so she and her provider can plan screening and ways to lower risk. The Everlywell product page says the same limit in direct words: Clairity Breast does not detect or diagnose breast cancer, and it does not replace a radiologist’s reading of the mammogram. A radiologist is the doctor who reads the image for signs of cancer today. The release also sets the new product next to other Everlywell cancer tests: an at-home colon cancer screening kit, a recently launched at-home HPV self-collection kit for cervical cancer screening, and access to a test that looks for many cancers at once. Those are other products. The release’s own next sentence is that Clairity Breast does not screen for or detect cancer.

The authorization, in the release’s dates. In 2025, Everlywell says, 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. De Novo is the Food and Drug Administration path for a new kind of device that does not already have a close match on the market. The About Clairity Breast box on the same release dates that authorization to May 2025. In 2026, the release says, updated NCCN guidelines introduced AI-based mammogram risk assessment as an option for identifying women at increased risk, beginning at age 35. NCCN is the National Comprehensive Cancer Network. Its cancer guidelines are the ones many U.S. clinics use. Clairity Breast is included in the NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis. Those lines are on the October 1 release. The product page’s first footnote points to Clairity’s June 2, 2025 announcement of the authorization. That footnote is a link the product page prints. The October 1 About box is the page that says May 2025.

Where a woman could get it before Thursday, and where she can get it now. The release says availability had been limited to health systems, including Beth Israel Deaconess Medical Center in Massachusetts and Invision Sally Jobe in Colorado. The Everlywell partnership is the nationwide step. Patients across the United States with a qualifying screening mammogram from the past 12 months can access the assessment on Everlywell. Access includes review and ordering by a licensed provider in Everlywell’s affiliated clinician network. A licensed provider, here, is a clinician allowed to order a medical test. Affiliated means that clinician works with Everlywell. Results are reviewed and released by a licensed provider, with next steps based on national guidelines. A woman can share the result with her own provider. The release says Everlywell’s clinical team is available for questions about the result. Those lines are Everlywell’s.

The release’s reason for looking past family history. About 85 percent of breast cancers occur in women with no family history of the disease. Eighty-five percent is a bit more than four in five. Clairity Breast, the release says, uses the routine mammogram rather than family history alone. The About Clairity section says the software looks for subtle patterns in a routine mammogram that are invisible to the human eye, so a clinician and a patient can understand future risk. That “invisible” line is Clairity’s description of the method. Dr. Connie Lehman, founder and chief executive of Clairity and a professor of radiology at Harvard Medical School, is quoted on the release. She said the information needed to understand a woman’s breast cancer risk “has been in her mammogram all along,” and that Clairity Breast is what makes it possible to interpret, so it can inform a conversation with a healthcare provider about screening and risk reduction. Julia Cheek, founder and chief executive of Everlywell, is quoted saying a woman can learn more about her future breast cancer risk from the mammogram she already gets, and walk into her doctor’s office with information she has not had before. The release also says both companies are founded and led by women. Those quotations are theirs, in the wire.

Two different study counts, from two Everlywell pages, for the same product. The About Clairity Breast box on the October 1 release says Clairity Breast was validated in more than 77,000 screening mammograms at five U.S. sites for the FDA authorization, and in more than 120,000 screening mammograms across 10 U.S. facilities after that authorization. More than 77,000 is the count the box ties to the authorization. More than 120,000 is a later count, at more sites. The product page uses a larger figure. It says the data are backed by studies including more than 250,000 screening mammograms in women across the United States and Europe. It says the software was trained on more than 250,000 mammograms linked to five years of real outcomes, including women who did and did not develop breast cancer. Its question-and-answer section says the tool was tested on more than 250,000 mammograms. The page’s footnotes point to the June 2, 2025 Clairity announcement and to two RSNA 2025 meeting abstracts. RSNA is the Radiological Society of North America, the large radiology meeting. The product page’s 250,000 and the release’s 77,000 and 120,000 are different counts. They are not one study written two ways.

What the product page says a mammogram must be, and what the test costs. The price on the page is $249. The page says FSA and HSA cards are accepted. An FSA is a flexible spending account. An HSA is a health savings account. Both are ways a person sets aside her own money for health costs. The page does not say a health insurer pays the $249. A compatible image is a standard digital screening mammogram from a Hologic Selenia or Selenia Dimensions machine, from the last 12 months. The page’s imaging answer is more specific. Clairity Breast analyzes full-field digital mammograms, or 2D images taken directly, from Hologic Lorad Selenia and Selenia Dimensions systems. It does not analyze synthetic 2D images. A synthetic 2D image is a flat picture built from a 3D mammogram, rather than its own X-ray. A diagnostic mammogram, ordered to check a specific concern, does not qualify. Final compatibility is confirmed after purchase. If the images cannot be retrieved, are not compatible, or cannot be scored, Everlywell says the customer receives a full refund. The page also says the test is not for anyone under 18, anyone in current treatment for breast cancer who has not finished the first round of surgery or radiation, or anyone with a known high-penetrance inherited mutation such as BRCA1 or BRCA2. A high-penetrance mutation is a gene change that, on its own, raises risk a great deal. The page says the image-only models are not meant to replace genetic testing or a clinical risk assessment. They are meant to sit beside those methods.

What the number means, on the same product page. The result is an estimate of the percentage chance of a breast cancer diagnosis within five years after the mammogram. Average risk is a five-year estimate under 1.7 percent. Intermediate risk is 1.7 percent to 2.9 percent. High risk is 3 percent or higher. For an average score, the page says the usual plan is to keep yearly mammograms, and that the score does not mean the risk is zero. For intermediate and high scores, the page says a yearly breast MRI, with and without contrast, is recommended for consideration, along with yearly mammograms and regular breast visits. An MRI is a different scan, using magnets rather than X-rays. Contrast is a dye given so the scan can show more. The page also says scores above 5 percent should be read with caution. It says every score above 5 percent is treated as high risk, and that high scores from the model may overestimate risk by a lot, especially scores above 10 percent. The page advises repeating the assessment with each new screening mammogram.

The steps after someone pays, on the product page. The customer fills in details about the last mammogram and the imaging center, and signs a release so Clairity can request the images. She does not upload the file herself. If she does not yet have an eligible mammogram, Everlywell says it will help find a compatible imaging center. Once the images are in, the result is reviewed and shared in the MyEverly portal, with guidance to discuss with a provider. Clairity’s own site says the five-year score is now available through Everlywell, with results reviewed by a licensed provider and next steps drawn from national guidelines. That line is Clairity’s, on clairity.com.

The picture is the Clairity Breast product image on Everlywell. A woman with curly gray hair sits on a light sofa, holding a tablet, with orange pillows to either side. A white card over the photograph reads “Clairity Breast™ 5-year Risk Score.” The card marks the result Average, and the figure is 1.2 percent. A bar under the words runs from green through amber to pink, with labels at 1.7 and 3. Those labels match the product page’s cutoffs: under 1.7 percent is average, and 3 percent or higher is high. The 1.2 percent on the card is the example the product image shows. It is not a named patient’s result. The card does not print a calendar date.

In plain terms, Everlywell said on Thursday that a woman in the United States with a screening mammogram from the past year can order Clairity Breast on its site. The listed price is $249. A licensed clinician in Everlywell’s network orders the test and releases the result. The software estimates five-year breast cancer risk from that mammogram. It does not find cancer on the image, and it does not replace the radiologist’s report. The FDA authorization is the 2025 De Novo, dated May 2025 in the release’s About box. The October 1 news is the nationwide consumer launch. The mammogram has to come from a Hologic Selenia or Selenia Dimensions machine. If it cannot be scored, Everlywell says the customer is refunded in full.