# EMA and FDA regulatory qualification of AIM-MASH AI Assist

PathAI's AIM-MASH AI Assist received both European Medicines Agency qualification and US FDA Drug Development Tool qualification in 2025, making it an AI-assisted pathology scoring tool for enrollment and endpoint assessment in MASH clinical trials. MASH liver biopsy scoring has long suffered from inter-reader and intra-reader inconsistency, which can dilute enrolled populations and depress observed treatment effects. The tool predicts MASH CRN grades and stages from whole slide images, and across 1,400 biopsies AI-assisted pathologists matched the median agreement of three unassisted pathologists with consensus ground truth.

PathAI's AIM-MASH AI Assist received both European Medicines Agency qualification and US FDA Drug Development Tool qualification in 2025, making it an AI-assisted pathology scoring tool for enrollment and endpoint assessment in MASH clinical trials. MASH liver biopsy scoring has long suffered from inter-reader and intra-reader inconsistency, which can dilute enrolled populations and depress observed treatment effects. The tool predicts MASH CRN grades and stages from whole slide images, and across 1,400 biopsies AI-assisted pathologists matched the median agreement of three unassisted pathologists with consensus ground truth.