Artera has achieved a major regulatory milestone with the U.S. FDA granting Breakthrough Device Designation to its AI-powered tool, ArteraAI Prostate—a first-of-its-kind multimodal artificial intelligence (MMAI) solution designed to assist clinicians in the management of localized prostate cancer. This innovative software analyzes digital pathology images from prostate biopsy slides to predict long-term outcomes, including the 10-year risk of distant metastasis and prostate cancer-specific mortality. The technology offers a data-driven, personalized approach to treatment planning, helping clinicians more accurately stratify patient risk and make informed therapeutic decisions tailored to each case.

The FDA’s Breakthrough Device Designation underscores the clinical importance and transformative potential of ArteraAI Prostate. The designation accelerates the review process for medical devices that offer significant advantages over existing options for life-threatening or irreversibly debilitating diseases. As the first and only AI risk stratification tool for prostate cancer to receive this recognition, ArteraAI Prostate stands out for its capacity to bring precision oncology directly into the hands of pathologists and treating physicians. Unlike traditional send-out genomic tests, this platform integrates directly into clinical workflows, offering faster insights and greater accessibility.

With over 3.5 million men in the U.S. living with prostate cancer, and a new diagnosis every two minutes, Artera’s AI technology arrives at a critical juncture in cancer care. By delivering powerful, individualized risk assessments, it bridges the gap between diagnosis and optimal treatment, helping avoid both overtreatment and undertreatment. This designation marks a significant step forward not only for Artera but for the broader field of AI in oncology—paving the way for smarter, more scalable solutions that improve outcomes and support clinicians in making confident, patient-specific care decisions.