The US Food and Drug Administration (FDA) has officially qualified AIM-NASH, the first artificial intelligence (AI) tool designed to help doctors assess metabolic dysfunction-associated steatohepatitis (MASH) during drug trials.

This advancement is set to make clinical research more efficient, raising hopes for quicker development of new therapies for a disease that affects millions and currently lacks approved treatments.

AIM-NASH works by analysing digital images of liver biopsy tissue, automatically identifying and measuring signs of fat accumulation, inflammation and scarring—key indicators of MASH.

Traditionally, evaluating these biopsies has required several pathologists to independently review each sample, often resulting in delays and inconsistencies. AIM-NASH changes this by generating standardised scores based on established medical guidelines, which physicians then use as part of their final review.

FDA studies demonstrated that the AI’s assessments were highly comparable to those performed by experienced human experts, supporting its qualification for use in any drug trial targeting MASH.

This marks a major step for the adoption of AI in clinical research, as pharmaceutical companies seek ways to reduce costs and speed up development timelines.

MASH is a growing health issue closely linked to obesity and diabetes, and can silently progress to severe complications like liver failure or cancer.

Slow, labour-intensive clinical trial processes have long hindered the search for effective treatments. By bringing consistency and speed to biopsy analysis, AIM-NASH may allow drug developers to run trials more efficiently—potentially halving both time and expense over the next few years.

For patients living with MASH, the FDA’s decision could mean faster access to new therapies and improved outcomes.

It also reflects the increasing role of artificial intelligence in healthcare, pointing towards a future where complex diseases are diagnosed and treated with greater accuracy and speed.