FDA Qualifies First AI Drug Development Tool, Will Be Used in ‘MASH’ Clinical Trials

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.