FDA Approves First AI Tool to Aid MASH Clinical Trials

The U.S. Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) tool for drug development in clinical trials. The system, called AIM-NASH (AI-Based Histologic Measurement of NASH), is designed to assist in evaluating liver histology in metabolic dysfunction-associated steatohepatitis (MASH) trials.

MASH can progress to cirrhosis, liver cancer, transplantation, or death. Current trials rely on multiple pathologists to assess liver biopsies, a slow process with variable scoring. AIM-NASH uses AI algorithms to analyze biopsy images and provide scores based on the NASH Clinical Research Network (NASH CRN) system. Validation studies showed its results align closely with expert consensus, similar to comparisons between individual pathologists and consensus readings.

The tool is meant to support—not replace—pathologists. Clinicians review both the AI outputs and full slides before final scoring. Sponsors should submit their AIM-NASH integration plans early to ensure proper use alongside existing consensus methods.

20-01-2026