FDA Grants First De Novo Authorisation for AI Prostate Cancer Software

The US FDA has granted de novo authorisation to Artera’s ArteraAI Prostate, the first AI-powered software designed to predict long-term outcomes in non-metastatic prostate cancer. Classified as a software as a medical device (SaMD), it can now be deployed in qualified pathology labs across the US.

The authorisation also establishes a new product code for future AI-driven digital pathology applications and includes a Predetermined Change Control Plan, allowing Artera to expand compatibility with additional scanners without new 510(k) submissions.

ArteraAI Prostate builds on the company’s multimodal AI (MMAI) platform, which integrates digital biopsy imaging and clinical data to predict hormone therapy response and long-term prognosis. The technology has been validated in multiple Phase III clinical trials.

Artera’s portfolio spans prostate and breast cancer diagnostics, with recent partnerships, including Tempus (2025), aimed at widening access to its AI-based prostate cancer test.

14-08-2025