FDA OKs Artera’s AI Platform for Breast Cancer

Artera, developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, has received U.S. Food and Drug Administration (FDA) clearance for its ArteraAI Breast for patients with early-stage, hormone receptor-positive (HR+), HER2-negative invasive breast cancer.

According to the company, ArteraAI Breast is the first and only FDA-cleared digital pathology-based risk stratification tool for breast cancer. It boasts clearances for both prostate and breast cancer and the company is expanding the platform across additional oncology indications.

ArteraAI Breast generates an AI-derived risk score that offers prognostic information on the likelihood of distant metastasis in patients with early-stage HR+/HER2- breast cancer. It utilizes digitized histopathology images and patient clinical variables to stratify patients in low- and high-risk groups, based on a predefined risk score cutoff.

“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.”

Data presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) evaluated the model in early-stage breast cancer and demonstrated the potential to inform chemotherapy benefit in certain patient populations.

“This clearance represents an important advance on the road to personalizing treatments for patients with early-stage breast cancer,” said Eric Winer, MD, 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.”

ArteraAI Breast was engineered to integrate directly into standard pathology workflows using routine surgical resection samples without needing additional tissue or separate specimen collection. This approach lets the software provide same-day results so pathology labs can provide patient-specific prognostic risk information along with standard histopathology reports.