Lung Macrodissect AI is an AI-powered tool that quantifies tumor content and guides ROI selection to enhance macrodissection workflows and downstream molecular analysis in cases of non-small cell lung cancer.
Regulatory Compliance
Lung Macrodissect AI is not a medical device in the EU/UK and is not intended to be used for diagnostic purposes. Lung Macrodissect AI is accessed via the HALO AP® enterprise digital pathology platform. Lung Macrodissect AI is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use.
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.