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 FDA-regulated Software as a Medical Device (SaMD). The technology’s De Novo authorization establishes a new product code category for future AI-powered digital pathology risk-stratification tools, and enables its implementation at the point of diagnosis at qualified pathology labs in the U.S. This capability addresses a critical gap in prostate cancer care by reducing delays in delivering actionable insights at diagnosis, helping clinicians and patients make informed treatment decisions with greater confidence.
“This is a defining moment for AI in cancer care,” said Andre Esteva, CEO and co-founder of Artera. “The FDA's decision validates the power of our MMAI platform to deliver on our vision to create AI-guided tools that enable data-backed and tailored treatments for each patient, leading to more confidence throughout the cancer journey, and ultimately, save more lives.”
“This approval highlights the groundswell of excitement surrounding the incorporation of AI into clinical practice flows. We need to utilize deep learning AI models to augment and better refine what a pathologist is able to report and Artera is leading the charge,” said Dr. Adam Cole, Founder and CSO at TruCore Pathology Group. “As the demand for pathology services continues to outpace available capacity, tools like ArteraAI Prostate are critical. Implementing this software enhances our ability to deliver personalized insights more quickly, improves workflow efficiency, and allows us to scale services while increasing the quality of care.”
Earning FDA De Novo authorization is a rare achievement, designed for novel medical innovations. This accomplishment marks yet another milestone for Artera, spotlighting its leadership and unwavering commitment to scientific rigor and excellence. Notably, the FDA authorization includes a Predetermined Change Control Plan, granting Artera the ability to expand platform capabilities through validating compatibility with additional digital pathology scanners without requiring further 510(k) submissions.
The De Novo authorization for ArteraAI Prostate follows its earlier Breakthrough Device Designation. While the De Novo authorization applies specifically to the ArteraAI Prostate medical device software, Artera’s underlying MMAI platform is also commercially available through the ArteraAI Prostate Test, as a Laboratory Developed Test (LDT). With this milestone, Artera continues to expand its pipeline of MMAI-powered software to support personalized cancer care.
To learn more, visit Artera.ai.
November 29, 2025 
