AI-Digital Pathology Software for Prostate Cancer Care Receives FDA De Novo Marketing Authorization

tim.hodson

Thu, 08/14/2025 – 16:54

Aug. 13, 2025 — Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, recently announced that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI Prostate, establishing it as the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer.
ArteraAI Prostate is now recognized as an …

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