US FDA Qualifies First AI Tool to Accelerate Liver Disease:
The U.S. Food and Drug Administration (FDA) has qualified the first AI-powered tool designed to assist doctors in assessing a severe form of fatty liver disease during drug trials. The tool, called AIM-NASH, marks a major advancement in how artificial intelligence can be used to accelerate drug development, improve diagnostic consistency, and reduce the resource burden on researchers.AIM-NASH is a cloud-based artificial intelligence system that analyzes liver biopsy images to help clinicians evaluate markers of liver disease, including fat accumulation, inflammation, and scarring.These biomarkers are essential in diagnosing and tracking metabolic dysfunction-associated steatohepatitis (MASH), a progressive condition affecting millions of Americans and one that can lead to liver failure or cancer.The tool uses advanced AI algorithms trained on large datasets to generate standardized scores that are then reviewed by doctors for final interpretation.By automating a key diagnostic step, AIM-NASH addresses variability and delays that currently burden clinical research.


