Medscape March 26, 2025
The European Medicines Agency (EMA) offered a positive opinion last week on a new artificial intelligence (AI)–based tool that supports pathologists in diagnosing and assessing the severity of metabolic dysfunction–associated steatohepatitis (MASH) during clinical trials. This is the first “qualification opinion” by the EMA’s human medicines committee (Committee for Medicinal Products for Human Use [CHMP]) on an innovative development methodology based on AI. It means that the committee can now accept evidence generated by the tool as scientifically valid in future applications and assessments for new MASH treatments.
MASH is a condition linked with obesity, type 2 diabetes, high blood pressure, abnormal cholesterol, and belly fat. It causes fat buildup in the liver, leading to inflammation, irritation, and scarring, even...
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