20 March 2025
EMA: Qualification of first artificial intelligence tool to diagnose inflammatory liver disease in biopsy samples
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has issued the first Qualification Opinion (QO) on an innovative development methodology based on artificial intelligence (AI). The tool, which is called AIM-NASH, can help pathologists analyse liver biopsy scans to identify the severity of metabolic dysfunction associated steatohepatitis (MASH; formerly known as non-alcoholic steatohepatitis (NASH)) in clinical trials. The data presented to CHMP demonstrates that AIM-NASH biopsy assessments, validated by a single expert pathologist, can accurately measure MASH disease activity with reduced variability compared to the current clinical trial standard, which requires consensus from three independent pathologists.
For more information, see here.
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