Artera Wins FDA De Novo Nod for AI Digital Pathology Software for Prostate Cancer

Artera has received U.S. Food and Drug Administration (FDA) de novo authorization for ArteraAI Prostate, an artificial intelligence (AI)-powered software that prognosticates long-term outcomes for patients with non-metastatic prostate cancer.

ArteraAI Prostate if now recognized as an FDA-regulated Software as a Medical Device (SaMD). The de novo nod establishes a new product code category for future AI-powered digital pathology risk-stratification tools. It also allows its implementation at the point of diagnosis at qualified U.S. pathology labs.

The company believes its technology addresses a critical gap in prostate cancer care by reducing delays in providing actionable insights at diagnosis.

The de novo authorization follows ArteraAI Prostate’s earlier breakthrough device designation. Notably, the 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.

Dr. Adam Cole, Founder and CSO at TruCore Pathology Group said the 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,” Dr. Cole told the press “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.”

Artera’s underlying MMAI platform is also commercially available through the ArteraAI Prostate Test, as a Laboratory Developed Test (LDT).

“This is a defining moment for AI in cancer care,” said Andre Esteva, co-founder and CEO 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.”