Pathology
ArteraAI Prostate
Artera Inc.
FDA
FDA-cleared AI medical device
Software-only device that analyzes scanned hematoxylin-and-eosin-stained whole-slide images from treatment-naïve prostate core-needle biopsies to provide 10-year risks of distant metastasis and prostate-cancer-specific mortality, intended to assist physicians with prognostic risk-based decisions in non-metastatic prostate cancer.
FDA Submission Metadata
- Submission number
- DEN240068
- Decision date
- July 2025
- FDA panel
- Pathology
- Product code
- SFH
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA