September 2025—The FDA has granted breakthrough device designation to Artera’s ArteraAI Prostate, an AI precision medicine tool intended to assist clinicians with risk-based decisions for patients with localized prostate cancer. ArteraAI Prostate analyzes digital pathology images of a patient’s prostate cancer biopsy slide to prognosticate long-term outcomes, such as 10-year risk of distant metastasis and prostate-cancer specific mortality, to help clinicians determine the most appropriate treatment option.
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