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Posted on March 20, 2025
2 min readLast updated: January 24, 2026
Add as preferred source on GoogleEMA approves AIM-NASH AI tool for assessing fatty liver disease severity in trials, enhancing accuracy and reducing variability.
(Reuters) -A European Medicines Agency committee, on Thursday, accepted the use of an artificial intelligence (AI) tool called AIM-NASH in clinical trials to help identify the severity of a type of fatty liver disease.
The condition, called metabolic dysfunction-associated steatohepatitis, or MASH, is a difficult-to-treat disease that affects around 1.5% to 6.5% of adults in the U.S., according to the American Liver Foundation.
The AI-based AIM-NASH tool employs a machine learning model trained on more than 100,000 annotations from 59 pathologists who assessed over 5,000 liver biopsies across nine large clinical trials.
The EMA's human medicines committee (CHMP) said evidence showed the AI tool can reliably determine disease activity from biopsies with less variability than the current standard in trials that rely on a consensus of three pathologists.
On that basis, the CHMP concluded, it can accept evidence generated by the tool as scientifically valid, which will help researchers obtain clearer evidence on the benefits of new treatments in clinical trials.
Currently, Madrigal Pharmaceuticals', Rezdiffra is the only U.S.-approved drug for MASH.
Drugmakers such as Novo Nordisk and Eli Lilly are also conducting trials with their blockbuster GLP-1 treatments to treat patients with the liver disease.
(Reporting by Christy Santhosh in Bengaluru; Editing by Savio D'Souza)
The main topic is the EMA's approval of the AIM-NASH AI tool for use in clinical trials for fatty liver disease.
AIM-NASH is an AI tool designed to assess the severity of metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials.
The AI tool reduces variability in assessing disease activity, providing clearer evidence for new treatments.
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