Fatty liver disease: The US Food and Drug Administration has qualified the first artificial intelligence tool designed to assist doctors in assessing a severe form of fatty liver disease in drug trials, the agency said.
The tool, which will be publicly available for use in drug development within its qualified context, is expected to support clinical research for metabolic dysfunction-associated steatohepatitis (MASH). The condition affects millions of Americans and can progress to serious complications, including liver failure and cancer.
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The cloud-based system, called AIM-NASH, analyses images of liver tissue to help identify and score key disease features such as fat accumulation, inflammation and scarring. Physicians then review the AI-generated scores for final interpretation.
The FDA said the tool could improve consistency in trial assessments. At present, multiple experts often review liver biopsies independently, a process that can be time-consuming and may produce variable results. By standardising evaluation, the agency noted, the technology could reduce delays and help streamline the path for new MASH treatments.
The FDA’s decision was supported by studies showing that assessments aided by AIM-NASH were comparable to evaluations performed by individual expert reviewers.
