Artera has obtained US Food and Drug Administration (FDA) clearance for ArteraAI Breast, making it the first digital pathology–based risk stratification tool for breast cancer to receive clearance from the agency.
ArteraAI Breast, a software tool that runs on Artera’s core multimodal artificial intelligence (MMAI) platform, applies AI to evaluate digital histopathology images of patients’ tumour tissue alongside clinical data to stratify them into low- and high-risk groups based on a predefined risk score cutoff.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
These risk scores are intended to define the likelihood of distant metastasis in patients with early-stage, hormone receptor-positive (HR+), HER2-negative breast cancer and to guide treatment decisions for patients.
HR+/HER2- is widely recognised as the most common breast cancer subtype. However, individual tumour behaviour, influenced by a range of biological and pathological factors, can make treatment intensity determinations a challenge. Artera asserts that pathology-based risk stratification for breast cancer patients can support clinicians in contextualising risk “within established clinical decision-making frameworks”.
Risk contextualisation, therefore, is viewed as a means to more accurately determine which HR+/HER2- negative patients would initially be most likely to benefit from chemotherapy, or less intense treatment modalities such as endocrine therapy. Knowing that a patient has a lower risk score, for instance, makes them a more suitable candidate for less intensive therapy, meaning they would not be unduly exposed to higher toxicity levels associated with certain therapies.
For Artera, ArteraAI Breast’s FDA clearance follows its receipt of a European CE mark alongside the company’s flagship prostate cancer assay in April 2026. ArteraAI Prostate gained de novo classification from the FDA in August 2025.
Artera CEO, Andre Esteva, said: “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 individualised risk. Our goal remains consistent across prostate and breast cancer, and beyond: to help clinicians translate complex data into more precise, personalised treatment decisions across the cancer journey.”
AI is having a significant impact in the healthcare space and taking up a particularly dominant role in diagnostic medical imaging. According to a report by GlobalData, the combined AI market across healthcare was valued at $11.9bn in 2024 and is expected to reach a valuation of $57.4bn in 2029.
