FDA Clears AI Digital Pathology Tool for Breast Cancer Risk Stratification

Risk assessment at diagnosis is central to guiding therapy for early-stage, hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) invasive breast cancer, where overtreatment and undertreatment remain clinical concerns. Traditional models often rely on variable clinicopathologic factors and may require additional testing or time. A newly FDA-cleared digital pathology software tool now provides same-day risk stratification for distant metastasis to support treatment planning.

Artera’s (Los Altos, CA, USA) ArteraAI Breast has received U.S. Food and Drug Administration (FDA) clearance for use in patients with early-stage HR+/HER2- invasive breast cancer and is the first and only FDA-cleared digital pathology–based risk-stratification tool for this disease. The software generates an AI-derived risk score that provides prognostic insight into the likelihood of distant metastasis. Using a predefined score cutoff, it stratifies patients into low- and high-risk groups.

Image: ArteraAI Breast analyzes digitized histopathology images alongside patient clinical variables to produce an AI-derived risk score that provides prognostic insight into the likelihood of distant metastasis (Image credit: Adobe Stock)

ArteraAI Breast analyzes digitized histopathology images alongside patient clinical variables to produce the score. The tool is designed to integrate into standard pathology workflows on routine surgical resection samples, requiring no additional tissue or separate specimen collection. Results can be produced the same day, enabling laboratories to return patient‑specific prognostic risk information with the standard histopathology report.

The U.S. FDA cleared ArteraAI Breast through the 510(k) pathway, expanding the company’s cleared platform beyond prostate cancer. The FDA clearance coincides with CE Marking for both the ArteraAI Prostate Biopsy Assay and the ArteraAI Breast Cancer Assay. Data presented at the 2025 San Antonio Breast Cancer Symposium evaluated the model in early-stage breast cancer and highlighted its potential to help inform chemotherapy benefit in select patient populations. By delivering consistent, pathology-based risk stratification at the point of diagnosis, the software is intended to support clinicians in contextualizing patient risk within established treatment decision frameworks.

“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” said Andre Esteva, CEO and co-founder of Artera. “This milestone reflects the growing role of our technology across multiple cancer types. Breast cancer care is highly nuanced, with treatment decisions that depend on individualized risk. 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.”

“This clearance represents an important advance on the road to personalizing treatments for patients with early-stage breast cancer,” said Eric Winer, M.D., medical oncologist and director of the Yale Cancer Center. “Using AI and digital pathology has the potential to streamline operational workflows, while creating a strong interdisciplinary linkage between oncology and pathology. This approach may further improve the clinicians' ability to help patients make the best treatment decisions.”

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