Artera

Artera, based in Los Altos, California, is the first company with FDA-cleared AI pathology tests that predict treatment benefit, with ArteraAI Prostate cleared de novo in 2025 and ArteraAI Breast in May 2026. Both tests were trained on pathology slides from phase 3 trial cohorts, which is what lets them claim predictive rather than only prognostic value. OnCo links it to prostate cancer, to digital pathology and pathology foundation models, to the bottleneck of AI that is built but not validated or deployed, and to the idea of patient-level multimodal foundation models for treatment selection. Whether clinicians and payers act on an AI test when it changes a treatment decision is the open question. Both tests have their own pages.