US EditionFDA Approves First AI Tool to Predict Breast Cancer Risk
- Clairity, Inc. Received FDA De Novo authorization in 2025 for CLAIRITY BREAST, an AI tool predicting five-year breast cancer risk from screening mammograms.
- This approval follows the need for improved risk assessment since 85% of breast cancer cases occur without family history and current models often miss high-risk women.
- CLAIRITY BREAST utilizes advanced AI to examine mammogram imaging details that are not discernible to the naked eye, producing a validated risk score designed to tailor screening strategies and support earlier breast cancer detection.
- Jeff Luber said the tool predicts risk before cancer appears, while Larry Norton called the FDA authorization a turning point for AI-driven cancer risk prediction access.
- Clairity plans to launch CLAIRITY BREAST across health systems by 2025, aiming to reduce late-stage diagnoses, lower costs, and expand preventative care for diverse populations.
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Now AI will also help in detecting breast cancer. Its name is Clairity Breast. According to media reports, every year more than 6 lakh deaths occur in the world due to breast cancer. However, now with the help of AI, breast cancer can be detected, and doctors will be able to treat it quickly. Watch the video to know more.
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FDA approves AI technology to help improve breast cancer detection
A breakthrough in AI breast cancer detection technology has been approved by the FDA. The tech company, “Clairity,” is responsible for the first FDA-approved AI platform that helps predict a woman’s risk of developing breast cancer in the next five years. We spoke with those who developed the AI platform and those in the medical community about how this helps with early detection. Eric Wiener, the director of Yale Cancer Center, said we are in t…
Clairity BREAST receives FDA authorization for AI-based breast cancer risk prediction
Clairity, Inc., a digital health innovator advancing AI-driven healthcare solutions, has received U.S. Food and Drug Administration (FDA) De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram.
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