PathAI announced that its AIM-MASH AI Assist tool is now the first and only AI-assisted pathology assessment technology qualified by the European Medicines Agency (EMA) CHMP for use in MASH (Metabolic dysfunction-associated steatohepatitis) clinical trials. The tool aids a single central pathologist in evaluating liver biopsies for both trial enrollment and endpoint assessment—potentially replacing multi-pathologist consensus reads. Clinical validation showed it outperformed human assessment for key features like inflammation and ballooning. This qualification marks a major step forward in AI-driven pathology and could accelerate drug development in MASH by ensuring more consistent, scalable biopsy analysis.
Keep Reading
Add A Comment