Overview

• On August 14, 2025, the FDA recognized ArteraAI Prostate as an FDA-regulated Software as a Medical Device and created a novel product code for similar AI digital pathology tools.
• The authorization incorporates a Predetermined Change Control Plan allowing Artera to validate additional digital pathology scanners without filing new regulatory submissions.
• This clearance follows a July 9 Breakthrough Device designation and is backed by Phase 3 trial findings, including STAMPEDE data, and validation results presented at ASCO 2025.
• Artera has launched the DIRECT-AI registry to gather real-world patient outcomes and assess the clinical impact of its prognostic and predictive software.
• ArteraAI Prostate holds a Category 2A recommendation in the NCCN Prostate Cancer Guidelines and is commercially available in the U.S. as a laboratory-developed test and via international distribution partners.