The digital pathology software provides same-day risk scores for patients with early-stage breast cancer to help guide treatment decisions.
The Food and Drug Administration (FDA) has cleared ArteraAI Breast, a digital pathology-based risk stratification tool for patients with early-stage, hormone receptor-positive, HER2-negative invasive breast cancer.
The platform uses digitized histopathology images and clinical variables to generate an AI-derived risk score that predicts the likelihood of distant metastasis. This score aims to help clinicians categorize patients into high- or low-risk groups using a predefined cutoff.
“FDA clearance for ArteraAI Breast represents a significant expansion of our FDA-cleared AI platform in oncology,” says Andre Esteva, CEO and co-founder of Artera, in a release. “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.”
The tool is designed to integrate into standard pathology workflows by using routine surgical resection samples. Because the software does not require additional tissue or separate specimen collection, it can provide same-day results. This allows pathology laboratories to include prognostic risk information alongside standard histopathology reports.
“Using AI and digital pathology has the potential to streamline operational workflows, while creating a strong interdisciplinary linkage between oncology and pathology,” says Eric Winer, MD, medical oncologist and director of the Yale Cancer Center, in a release. “This approach may further improve the clinicians’ ability to help patients make the best treatment decisions.”
The FDA clearance follows data presented at the 2025 San Antonio Breast Cancer Symposium that evaluated the model in early-stage breast cancer and demonstrated its potential to inform chemotherapy benefit in specific patient populations.
Artera also holds FDA clearance for its prostate cancer tool and recently received CE Marking for both its prostate and breast cancer assays, expanding its regulatory footprint in the US and Europe.
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