PathAI Secures FDA Qualification for AIM-MASH, the First AI-Enabled Pathology Tool for Drug Development

PathAI has reached a significant regulatory milestone with the U.S. Food and Drug Administration granting qualification to its AIM-MASH AI Assist tool through the Drug Development Tool Biomarker Qualification Program. This designation marks the first time an AI-enabled pathology biomarker has been formally recognized as a Drug Development Tool, following earlier qualification by the European Medicines Agency and creating the first dual U.S. and EU regulatory status for an AI pathology technology. The company positions the tool as a method to standardize liver biopsy scoring and reduce inter-reader variability, a long-standing challenge in clinical trials for metabolic dysfunction-associated steatohepatitis.

The reliance on manual microscopic evaluation has historically introduced inconsistencies in grading fibrosis, steatosis, ballooning, and inflammation. AIM-MASH is intended to address these reproducibility gaps by enabling a single pathologist, supported by the algorithm, to apply standardized enrollment and endpoint criteria across studies. Commenting on the regulatory decision, Naim Alkhouri, MD, FAASLD stated, “Dual qualification by the EMA and the FDA gives sponsors a regulator-approved path to use AI-assisted histology for Phases 2 and 3 MASH clinical trial enrollment and endpoint assessment. For MASH trials worldwide, that means greater consistency, reproducibility, and confidence in histologic endpoints.”

The FDA’s qualification was supported by a validation package that referenced evidence published in 2025 demonstrating the algorithm’s performance relative to manual reads. According to the data, AIM-MASH achieved non-inferiority to average individual pathologist assessments for fibrosis and steatosis, superiority to expert manual reads for ballooning and inflammation, and 100% repeatability with improved reproducibility across all precision metrics evaluated. Given the influence that small grading differences can have on drug efficacy determinations, regulators have signaled that such consistency may materially benefit trial integrity.

For pharmaceutical sponsors, the qualification provides a clarified regulatory pathway. AIM-MASH can now be incorporated into IND, NDA, and BLA submissions without the need to revalidate the tool’s methodology, potentially streamlining development timelines. The combination of U.S. and EU recognition is expected to support broader global adoption as companies pursue more uniform approaches to MASH trial design.

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