FDA Clears ArteraAI Breast for Breast Cancer Risk Stratification

TUESDAY, May 12, 2026 (HealthDay News) -- The U.S. Food and Drug Administration has cleared ArteraAI Breast for use in patients with early-stage, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative invasive breast cancer.The multimodal artificial intelligence-based prognostic and predictive cancer test is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer. ArteraAI Breast generates a risk score that predicts a low or high likelihood of distant metastasis in patients with early-stage HR-positive/HER2-negative breast cancer based on digitized histopathology images and patient clinical variables. The tool is designed to integrate directly into standard pathology workflows using routine surgical resection samples, without requiring additional tissue or separate specimen collection.The approval is based on previously presented data. In one poster presentation (12,000 patients across six phase 3 clinical trials), the model stratified patients by 10-year risk for distant metastasis. Identified high-risk individuals were recommended for closer monitoring, while 68 percent of patients were classified as low-risk and achieved an estimated 10-year distant metastasis-free survival of approximately 95 percent."Our goal remains consistent across prostate and breast cancer, and beyond: to help clinicians translate complex data into more precise, personalized treatment decisions across the cancer journey," Andre Esteva, CEO and cofounder of Artera, said in a statement.More Information.Sign up for our weekly HealthDay newsletter

FDA Clears ArteraAI Breast for Breast Cancer Risk Stratification

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