Artera Receives FDA De Novo Approval for AI-Powered Prostate Cancer Software, Paving the Way for Precision Oncology at Diagnosis

Artera, a pioneer in artificial intelligence-driven cancer diagnostics, has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for ArteraAI Prostate, making it the first and only AI-powered software cleared by the FDA to predict long-term outcomes for patients with non-metastatic prostate cancer. The approval marks a transformative milestone in precision oncology, positioning the technology as a regulated Software as a Medical Device (SaMD) and enabling its use at the point of diagnosis in qualified U.S. pathology labs. ArteraAI Prostate leverages the company’s multimodal artificial intelligence (MMAI) platform to analyze digitized biopsy images alongside clinical data, delivering prognostic and predictive insights that help guide treatment decisions. By providing actionable, data-driven information early in the diagnostic process, the tool helps reduce delays and supports more confident, personalized care for patients. “This is a defining moment for AI in cancer care,” said Andre Esteva, CEO and co-founder of Artera. “The FDA’s decision validates our mission to build AI tools that deliver tailored, evidence-based treatment options, giving patients and clinicians greater confidence and ultimately saving lives.” The De Novo authorization is a rare and significant achievement, reserved for novel medical devices with no legally marketed predicate. It establishes a new product code category for AI-based digital pathology risk-stratification tools, paving the way for future innovations in the field. Importantly, the approval includes a Predetermined Change Control Plan, allowing Artera to expand the platform’s compatibility with additional digital pathology scanners without requiring further FDA submissions. The authorization follows ArteraAI Prostate’s earlier Breakthrough Device Designation, underscoring its potential to address unmet clinical needs. While the De Novo clearance applies specifically to the software, Artera’s underlying MMAI platform is also available commercially as the ArteraAI Prostate Test, a Laboratory Developed Test (LDT), in the U.S. and internationally. Dr. Adam Cole, Founder and CSO at TruCore Pathology Group, highlighted the growing role of AI in pathology, noting that rising demand for services outpaces available capacity. “Tools like ArteraAI Prostate are essential,” he said. “They enhance diagnostic accuracy, improve workflow efficiency, and allow us to scale high-quality care without compromising on precision.” Artera’s pipeline includes additional MMAI-powered solutions such as the ArteraAI Breast Test (UKCA), ArteraAI Prostate Biopsy Assay (UKCA), and ArteraAI Prostate (FDA). The company’s CLIA-certified clinical laboratory is based in Jacksonville, Florida, with headquarters in Los Altos, California. For more information, visit artera.ai.