EMA’s human medicines committee (CHMP) has issued its first Qualification Opinion (QO) for an AI-based tool called AIM-NASH, designed to assist pathologists in analyzing liver biopsy scans to assess the severity of MASH (metabolic dysfunction associated steatohepatitis). MASH, linked to obesity and metabolic conditions, can lead to advanced liver disease if untreated. AIM-NASH aims to improve the accuracy and efficiency of clinical trials by reducing variability in measuring MASH disease activity, helping researchers obtain more reliable data with fewer patients. The tool is based on a machine learning model trained on data from over 5,000 liver biopsies.

Read the full press release here.