January 2026—PathAI announced that the Food and Drug Administration has qualified AIM-MASH AI Assist through the drug development tool (DDT) biomarker qualification program for use within a context of use in metabolic dysfunction–associated steatohepatitis (MASH) clinical trials. AIM-MASH AI Assist is the first AI-powered pathology DDT to receive FDA qualification. It received European Medicines Agency Committee for Medicinal Products for Human Use qualification in early 2025.
AIM-MASH AI Assist has the potential to accelerate the development of new treatments by providing more efficient and accurate assessments of biopsy-based patient response to drug candidates within and across MASH clinical trials, according to a company press release. The tool allows a pathologist to provide standardized, accurate MASH biopsy assessments at scale. It is not for use in diagnostic procedures.
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