U.S. Food and Drug Administration (FDA) Approves First AI Tool for Liver Disease Trials

Key facts

• The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials.
• This cloud-based tool helps pathologists score liver biopsy components, including fat infiltration (steatosis), inflammation (hepatocellular ballooning and lobular inflammation), and scarring (fibrosis) stage.
• MASH is a serious form of fatty liver disease where too much fat in the liver causes inflammation and scarring.
• The AIM-NASH system uses AI algorithms to analyze images of liver biopsies and provides scores according to the NASH Clinical Research Network scoring system, with pathologists fully responsible for final interpretation.