The U.S. Food and Drug Administration (FDA) has qualified the world’s first artificial intelligence tool designed to speed up drug development for liver disease. The cloud-based system, AIM-NASH, analyses digital images of liver biopsies to assess key features of metabolic dysfunction-associated steatohepatitis (MASH), including fat accumulation, inflammation and scarring. With this approval, AIM-NASH is now available for use in any drug-development programme targeting MASH under the qualified context of use.

Traditionally, evaluating MASH in clinical trials has required multiple pathologists to manually and independently assess liver tissue samples — a process that is time-consuming, costly and often inconsistent. AIM-NASH aims to overcome these challenges by providing standardised, AI-generated pathology scores that align with established scoring methods. Pathologists remain responsible for reviewing the AI’s output and making final determinations.

In validation studies, AIM-NASH-assisted assessments demonstrated performance comparable to evaluations by expert pathologist consensus, supporting its reliability and laying the groundwork for broader adoption. The system is expected to reduce the time, labour and expense involved in liver-disease clinical trials — potentially accelerating the development of new therapies for MASH by streamlining histological assessments.

This milestone represents a significant shift in how liver disease trials may be conducted in the future. By integrating AI into the drug development process, regulators and researchers are embracing digital innovation to address major bottlenecks in the evaluation of complex diseases. The qualification of AIM-NASH could pave the way for faster, more efficient clinical trials, bringing effective therapies to patients sooner.