Prostate AI is an automated, AI-based decision-support tool that quantifies tumor content and standardizes Gleason grading in prostate cancer on whole slide images (WSI). Prostate AI is seamlessly integrated into HALO AP.
Regulatory Compliance
Prostate AI is for Research Use Only and not intended for clinical diagnostic use. Prostate AI is accessed via the HALO AP® enterprise digital pathology platform.
HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP® is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. In addition, HALO AP® provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.