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
Accessing Breast IHC AI in our CE-marked case management and viewing platform, HALO AP®, provides end-to-end integration to scanners and LIS | LIMS while providing built in compliance and certifications: CE-IVD, FDA 21 CFR Part 11, ISO 13485:2016, HIPAA, and GDPR.
Breast IHC AI is for Research Use Only and not intended for clinical diagnostic use.
HALO AP® is CE-marked for in-vitro diagnostic use in Europe and the UK. HALO AP is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use.