FDA clears AI breast cancer stratification tool

Artera said on May 6 that the U.S. Food and Drug Administration cleared ArteraAI Breast, a digital pathology-based risk stratification tool for patients with early-stage hormone receptor-positive, HER2-negative invasive breast cancer. Cancer Network, citing an Artera press release, said the software generates an AI-assisted risk score that provides prognostic information on the risk of distant metastasis in that population. The FDA’s device database shows the product, ArteraAI Breast, was cleared under 510(k) number K254115 with a decision date of May 4, 2026. ### Which patients is this cleared for? ArteraAI Breast is cleared for use in patients with early-stage HR-positive, HER2-negative invasive breast cancer, according to Artera and Cancer Network. That is the most common subtype of breast cancer, and treatment choices after surgery can include endocrine therapy, chemotherapy and, in some cases, additional targeted drugs. (cancernetwork.com) The FDA decision summary says the software is intended to use whole-slide images from FDA-cleared interoperable scanners and validated file formats. The same document says it should be used together with a standard-of-care evaluation rather than as a stand-alone replacement for clinical judgment. ### What does the software actually do? (cancernetwork.com) Cancer Network said the tool uses digitized histopathology images and patient clinical variables to sort patients into low- and high-risk groups based on a predefined cutoff. Artera said the output is an AI-derived risk score meant to provide prognostic information on the likelihood of distant metastasis. (accessdata.fda.gov) Artera said the model is designed to support clinicians at or around diagnosis by adding pathology-based risk stratification to existing decision frameworks. The company also said results can be shared within one to two days after a sample is collected from a patient’s resection. (cancernetwork.com) ### What evidence did Artera cite? Cancer Network reported that Artera said the algorithm was developed using thousands of patients and tens of thousands of pathology slides. The report also said the tool showed prognostic value across nine phase 3 breast cancer trials in predicting distant metastasis risk in HR-positive early-stage disease. (cancernetwork.com) Artera said data presented at the 2025 San Antonio Breast Cancer Symposium evaluated the model in early-stage breast cancer and showed potential to inform chemotherapy benefit in certain patient groups. Cancer Network separately reported that the test showed independent prognostic and predictive performance for chemotherapy benefit in the NSABP B-20 trial, attributing that claim to the developer. (cancernetwork.com) ### Who is behind the product? Artera, based in the San Francisco Bay Area, develops multimodal artificial intelligence cancer tests. The company said this is its first FDA-cleared breast cancer product and described ArteraAI Breast as the first and only FDA-cleared digital pathology-based risk stratification tool in breast cancer. (artera.ai) Eric Winer, director of Yale Cancer Center, said in Artera’s release that the clearance “represents an important advance” in personalizing treatment for early-stage breast cancer. Andre Esteva, Artera’s chief executive and co-founder, said the decision expands the company’s FDA-cleared AI platform from prostate cancer into breast cancer. (artera.ai) ### Where can clinicians look next? The FDA’s public device record lists ArteraAI Breast under 510(k) number K254115, with Artera as the applicant and May 4, 2026 as the decision date. Artera’s May 6 release and the FDA decision summary provide the next level of detail on intended use, scanner compatibility and the conditions attached to the clearance. (accessdata.fda.gov) (artera.ai)