Breast IHC AI is an automated, AI-based decision-support tool that standardizes scoring of HER2, ER, PR, and Ki67 IHC assessment on whole slide images (WSI) in accordance with clinical scoring guidelines. Breast IHC AI is seamlessly integrated into HALO AP®.
Regulatory Compliance
Breast IHC AI is For Research Use Only and not intended for clinical diagnostic use. Breast IHC 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.