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FDA Authorizes First AI Platform for Breast Cancer Prediction
- The FDA approved Clairity Breast, the first AI platform predicting five-year breast cancer risk from screening mammograms in 2025.
- Clairity, established in 2020 by Dr. Connie Lehman, a specialist in breast imaging, achieved approval after its algorithm was tested on more than 77,000 mammograms.
- Clairity Breast analyzes 2D images to generate risk scores, aiming to reduce unnecessary biopsies and improve early detection through AI-informed second opinions.
- Lehman emphasized that the goal is to detect and identify the majority of breast cancer cases, which are considered sporadic and account for approximately 85% of occurrences, underscoring the shortcomings of older risk assessment models.
- The platform’s FDA clearance may expand AI use in mammography, potentially increasing accuracy, reducing costs, and enhancing patient confidence in breast cancer screening.
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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.
Revolutionizing FDA Operations: Meet Elsa, the AI Tool Transforming Public Health
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the official launch of Elsa, a cutting-edge generative Artificial Intelligence (AI) tool designed to optimize efficiency across the agency. This pivotal step reflects the FDA’s commitment to leveraging advanced technology to strengthen its operations and better serve public health. Unveiled on June 2, 2025, Elsa, which functions within a highly secure GovCloud environme…
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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.
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