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FDA Approves First AI Tool for MASH Clinical Trials, Paving the Way for Advanced Drug Development
The FDA has qualified AIM-NASH, the first AI-based tool designed to assist in clinical trials targeting metabolic dysfunction-associated steatohepatitis (MASH). This cloud-based tool helps pathologists accurately score liver biopsy features such as fat infiltration, inflammation, and fibrosis. With MASH affecting approximately 38% of adults worldwide and being a leading cause of chronic liver disease, this innovation is critical for accelerating the development of new therapies and improving patient outcomes. AIM-NASH’s FDA qualification means it can be used in any drug development program, supporting regulatory filings and potentially transforming how liver biopsy analyses are conducted in clinical settings. This advancement could reshape drug development in the hepatology field, offering a more standardized and efficient evaluation method. Stay informed to see how AI is revolutionizing clinical trials.
