HIT Consultant December 9, 2025
What You Should Know:
– PathAI has secured a historic regulatory milestone with the FDA qualification of its AIM-MASH AI Assist tool, making it the first AI-powered pathology biomarker to receive such status under the FDA’s Drug Development Tool (DDT) program. This follows a similar qualification from the European Medicines Agency (EMA) earlier this year, establishing AIM-MASH as the first tool of its kind to hold dual U.S. and EU regulatory recognition.
– By standardizing liver biopsy scoring, this AI technology promises to accelerate clinical trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH) by reducing human variability and enabling more accurate enrollment and endpoint assessment.
PathAI’s Dual FDA and EMA Win Signals a New Era for Clinical Trials
For decades, the...
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