The FDA has granted de novo authorization to ArteraAI Prostate, making it the first AI-powered tool authorized to prognosticate long-term outcomes in localized prostate cancer patients. This milestone establishes a new regulatory pathway for AI-powered digital pathology tools and enables immediate implementation in qualified US pathology labs.
Drug/Device Profile & Mechanism
- ArteraAI Prostate: Multimodal AI (MMAI) risk stratification tool for non-metastatic prostate cancer
- Technology: Analyzes digital biopsy images plus clinical data to predict 10-year distant metastasis risk and prostate cancer-specific mortality
- Patient Population: Patients with localized, non-metastatic prostate cancer at point of diagnosis
- Developer: Artera (CEO: Andre Esteva)
Regulatory Milestone Details
- De Novo Authorization: First-in-class designation establishing new product code category for future AI pathology tools
- Breakthrough Device Designation: Previously granted in July 2025, expediting regulatory review
- Predetermined Change Control Plan: Allows platform expansion to additional digital pathology scanners without requiring new 510(k) submissions
- Validation Data: Based on multiple phase 3 clinical trials with median 11.4-year follow-up
Practice Implications
- Immediate Availability: Can be implemented at qualified US pathology labs for commercial test ordering
- Treatment Selection: Identifies 34% of patients who may benefit from short-term hormone therapy (HR 0.34, 95% CI 0.19-0.63, P<0.001)
- Superior Performance: 9.2%-14.6% relative improvement over NCCN risk stratification models across all endpoints
- Personalized Care: Enables data-backed treatment decisions at diagnosis, potentially improving patient confidence and outcomes
Development Status & Next Steps
- Current Status: Commercially available through ArteraAI Prostate Test platform
- Future Expansion: Predetermined change control plan enables rapid platform scaling
- Supporting Evidence: Additional data presented at 2025 ASCO Annual Meeting from STAMPEDE trial
- Market Impact: First regulatory precedent for AI-powered cancer prognostication tools
Source: https://www.urologytimes.com/view/fda-grants-de-novo-authorization-to-arteraai-prostate
