US EditionFDA Authorizes First AI Platform for Breast Cancer Prediction
- The FDA approved the first AI platform, Clairity Breast, in 2025 to predict breast cancer risk from mammograms in the U.S.
- The approval came after Clairity was established in 2020 by Dr. Connie Lehman, an expert in breast imaging, with the goal of employing AI to identify subtle indicators of breast cancer risk within mammograms.
- The AI analyzes 2D mammograms from Hologic systems and generates a five-year cancer risk percentage, validated on over 77,000 images with outcome data.
- Clairity’s CEO Jeff Luber expects future expansion to 3D images, multivendor support, and international markets, aiming to surpass older risk models from largely European cohorts.
- The FDA’s use of AI in regulation and Clairity’s technology reflect a shift toward integrating AI to enhance accuracy, reduce unnecessary procedures, and improve breast cancer outcomes.
47 Articles
47 Articles
Fox News AI Newsletter: FDA approves cancer-fighting tech tool
IN TODAY'S NEWSLETTER:- FDA approves first AI tool to predict breast cancer risk- Kesha changes cover art for 'Delusional' single after fan backlash over AI image- OpenAI to appeal copyright ruling in NY Times case as Altman calls for 'AI privilege'SMARTER SCREENINGS: The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool to predict breast cancer risk.'WE WILL FIGHT': OpenAI CEO Sam Altman said Thurs…
Daily Journal
FDA Authorizes First AI Platform for Breast Cancer Prediction
FRIDAY, June 6, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has granted de novo authorization to CLAIRITY BREAST, a first-in-class, image-based platform that can help predict a woman's risk for breast cancer.
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FDA to Integrate Artificial Intelligence in Medical Device Review and Safety Monitoring
The U.S. Food and Drug Administration (FDA) has announc […] The post FDA to Integrate Artificial Intelligence in Medical Device Review and Safety Monitoring first appeared on GeneOnline News. The post FDA to Integrate Artificial Intelligence in Medical Device Review and Safety Monitoring appeared first on GeneOnline News.
How AI Is Enhancing Mammogram Accuracy
Routine mammograms are a cornerstone of women’s health, especially when it comes to the early detection of breast cancer. Yet, receiving a result—whether normal, suspicious, or unclear—can lead to lingering questions. Is the interpretation accurate? Was anything missed? Seeking a second opinion is a natural response, and with emerging technologies like artificial intelligence, getting that […] The post How AI Is Enhancing Mammogram Accuracy appe…
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