CRC Macrodissect AI is an AI-powered tool that quantifies tumor content and guides ROI selection to enhance macrodissection workflows and downstream molecular analysis in colorectal carcinoma.
Regulatory Compliance
CRC Macrodissect AI is for Research Use Only and not intended for clinical diagnostic use. CRC Macrodissect 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.