FDA Approves AIM-NASH: World’s First AI Tool for Liver Disease Drug Trials

FDA Approval Marks Breakthrough in AI-Driven Liver Disease Research

The US Food and Drug Administration has approved AIM-NASH, the world’s first artificial intelligence–powered tool designed specifically to support drug development for metabolic dysfunction-associated steatohepatitis (MASH). The approval marks a pivotal advance in clinical research, offering a pathway toward faster and more consistent biopsy evaluations—one of the most time-intensive steps in liver disease trials.

AI Brings Precision to Histologic Assessment

AIM-NASH evaluates high-resolution digital biopsy images and assigns quantitative scores to key liver injury markers, including hepatocellular ballooning, steatosis, lobular inflammation and fibrosis. These features are central to diagnosing MASH and tracking therapeutic progress. By generating standardised scores aligned with the NASH Clinical Research Network (NASH-CRN) system, the tool reduces the interpretational variability common among human pathologists.

Streamlining Clinical Trials With Faster, Reliable Scoring

Conventional MASH trials require several expert pathologists to independently review each slide—an approach that increases both timelines and inconsistency. AIM-NASH addresses this challenge by producing near-instant AI-aided evaluations. Importantly, the system retains human oversight: final diagnostic decisions rest with pathologists who review both full-slide images and AI outputs before validation.

Why MASH Diagnostics Are Critical

MASH, a progressive form of fatty liver disease, can lead to cirrhosis, liver failure and hepatocellular carcinoma if undetected or untreated. More accurate, reproducible biopsy evaluations are essential for assessing investigational therapies and accelerating the development of effective interventions.

Exam Oriented Facts

• AIM-NASH is the first FDA-approved AI tool for liver disease clinical trials.

• It interprets steatosis, ballooning, inflammation and fibrosis from biopsy images.

• Uses the NASH-CRN scoring framework for standardised assessment.

• Pathologists retain final authority in confirming AI-assisted readings.