The European Medicines Agency (EMA) has issued its first-ever Qualification Opinion (QO) for an AI-driven tool in medicine. AIM-NASH, an advanced AI system, is set to transform how liver diseases like MASH (Metabolic dysfunction-associated steatohepatitis) are diagnosed and treated in clinical trials.
MASH, formerly known as NASH, is a progressive liver condition linked to obesity, diabetes, and high cholesterol. Until now, liver biopsies—prone to human error—have been the gold standard for assessing the disease. AIM-NASH changes this by using AI to analyze liver biopsy scans with unprecedented accuracy, reducing variability and improving reliability.
Trained on over 5,000 liver biopsies and 100,000 expert annotations, the tool standardizes disease assessment, allowing clinical trials to generate clearer evidence with fewer patients. This means faster drug approvals and quicker access to life-saving treatments for millions affected by MASH.
With EMA’s endorsement, AIM-NASH marks a major step toward integrating AI into drug development, setting a new precedent for medical research.