Artera, a pioneer in multimodal AI (MMAI)-driven cancer diagnostics, has received U.S. FDA De Novo authorization for ArteraAI Prostate, making it the first and only AI-powered software cleared to predict long-term outcomes in non-metastatic prostate cancer.
Recognized as an FDA-regulated Software as a Medical Device (SaMD), this authorization establishes a new product code for future AI-powered digital pathology risk-stratification tools. It enables qualified pathology labs in the U.S. to integrate the technology at diagnosis, addressing delays in actionable insights and empowering clinicians and patients to make timely, informed treatment decisions.
“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 MMAI platform’s ability to guide tailored treatments, increase clinical confidence, and ultimately save lives.”
Dr. Adam Cole, Founder and CSO at TruCore Pathology Group, emphasized the importance of such AI tools in addressing growing demand for pathology services. “ArteraAI Prostate improves workflow efficiency, delivers personalized insights faster, and supports scaling while maintaining high-quality care,” he said.
The De Novo authorization—a rare distinction for novel medical innovations—includes a Predetermined Change Control Plan, allowing Artera to expand scanner compatibility without further 510(k) submissions. This follows the platform’s earlier Breakthrough Device Designation and strengthens Artera’s leadership in AI-driven personalized cancer care. The company continues to expand its MMAI-powered solutions through its commercial ArteraAI Prostate Test and future products in development.