SAN FRANCISCO — Artera, a developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, has received U.S. Food and Drug Administration (FDA) De Novo marketing authorization for ArteraAI Prostate, making it the first and only AI-powered software authorized to predict long-term outcomes for patients with non-metastatic prostate cancer.
The FDA’s decision classifies ArteraAI Prostate as a regulated Software as a Medical Device (SaMD) and establishes a new product code category for future AI-powered digital pathology risk-stratification tools. The technology can now be implemented at qualified pathology labs in the U.S. at the point of diagnosis, providing clinicians with earlier access to actionable insights to guide 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 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.”
Dr. Adam Cole, founder and chief scientific officer at TruCore Pathology Group, said, “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. 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.”
The De Novo authorization, which follows an earlier Breakthrough Device Designation, also includes a Predetermined Change Control Plan that allows Artera to expand platform capabilities by validating compatibility with additional digital pathology scanners without requiring new 510(k) submissions.
While the authorization applies specifically to the ArteraAI Prostate medical device software, the company’s MMAI platform is also commercially available through the ArteraAI Prostate Test as a Laboratory Developed Test. Artera said it will continue to expand its pipeline of AI-powered software to support personalized cancer care.
