ArteraAI Breast receives FDA clearance as first digital pathology breast cancer risk tool

The FDA granted clearance to ArteraAI Breast, making it the first digital pathology-based risk stratification tool for breast cancer. The tool uses multimodal AI combining digitized histopathology images with clinical data to generate an AI-derived risk score that stratifies early-stage HR+/HER2- breast cancer patients into low- and high-risk categories for distant metastasis. Clinical validation data was presented at the 2025 San Antonio Breast Cancer Symposium. The tool integrates into standard pathology workflows using routine surgical samples, enabling same-day reporting. ArteraAI Prostate previously received FDA de novo classification in August 2025.