Artera Receives U.S. FDA De Novo Marketing Authorization for AI-Digital Pathology Software Revolutionizing Prostate Cancer Care

August 13, 2025 at 09:02 AM EDT

Novel risk stratification tool advances the frontier of precision oncology by providing access to insights informing critical on-the-ground treatment decisions

Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today 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.

About Artera

Artera is a global leader in precision medicine, leveraging multimodal artificial intelligence (MMAI) to personalize cancer care. Artera’s MMAI platform leverages a patient’s digitized biopsy images along with the patient’s clinical data to determine cancer aggressiveness and predict therapy benefit. This approach has been validated in multiple Phase 3 randomized trials, across different cancers, and is available in multiple versions across the globe.

Artera’s flagship product, the ArteraAI Prostate Test, is commercially available as a laboratory-developed test in the US and internationally through its distribution partners. The ArteraAI Prostate Test is the first of its kind to deliver both prognostic and predictive insights for patients with prostate cancer, empowering clinicians and patients to make more informed treatment decisions.

Additional MMAI-powered products include the ArteraAI Breast Test (UKCA), the ArteraAI Prostate Biopsy Assay (UKCA), and ArteraAI Prostate (FDA). Artera has regulatory authorization for its medical device product in the US and UK.

Artera’s headquarters is based in Los Altos, California, while its CLIA-certified and clinical laboratory is located in Jacksonville, Florida. For more information about Artera, visit artera.ai.