Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration has formally qualified the first artificial intelligence tool through its Drug Development Tool (DDT) Qualification Program. The AI tool called AIM-NASH is now authorized for use in clinical trials for metabolic dysfunction–associated steatohepatitis (MASH), a progressive and potentially severe liver disease affecting millions worldwide.
The qualification shows confidence in AI-based imaging analysis for assessing disease severity and monitoring treatment response, especially in conditions where noninvasive and reproducible measurement tools are needed.
How AIM-NASH Functions
The tool uses machine learning to analyze liver imaging scans. It detects and quantifies features related to MASH pathology, such as inflammation, steatosis, and fibrosis. The FDA determined that the tool can support consistent, reliable, and repeatable assessment of disease severity in clinical trial settings.
This reduces the dependence on liver biopsies, which are invasive, variable, and often difficult to repeat over time. By providing standardized metrics that trial sponsors can rely on, the AIM-NASH helps shorten timelines and supports development of new therapies for MASH, a field that has seen many late-stage trial failures.
PathAI, a Boston-based leader in AI-powered pathology, developed AIM-NASH to standardize liver biopsy analysis in MASH trials. The tool’s machine learning model draws from over 100,000 annotations by 59 pathologists across more than 5,000 biopsies from nine clinical trials, enabling precise scoring of disease features.
MASH
MASH represents a severe progression of metabolic-associated fatty liver disease, affecting millions in the U.S. and potentially leading to cirrhosis, liver failure, cancer, transplantation, or death.
In MASH clinical trials, traditional liver biopsy reviews require several independent experts to score samples separately, leading to inconsistent results, long wait times, and heavy costs due to the labor-intensive process.
AIM-NASH tackles these issues head-on by using AI to deliver consistent, standardized scoring of key features like fat buildup, cell damage, inflammation, and scarring across biopsies.
This uniformity helps streamline trial workflows, cut down evaluation delays from weeks to days, lower expenses through reduced expert consultations, and enable faster progression of potential MASH treatments to patients.
Understanding FDA’s Drug Development Tool (DDT) Qualification Programs
The FDA’s Drug Development Tool (DDT) Qualification Programs are formal pathways that evaluate and validate tools designed to make drug development more efficient, reliable and scientifically robust. These programs provide a structured process that allows new biomarkers, clinical outcome assessments and innovative methods to be used consistently across clinical trials without repeated review for each study.
The goal is simple; reduce uncertainty in drug development by qualifying tools that are proven to be accurate, reproducible and useful in a defined context.
Why DDT Qualification Matters
Drug development often struggles with slow timelines, variable endpoints and lack of standardized tools. By qualifying tools that can reliably measure disease progression, treatment response or patient experience, the FDA helps sponsors design stronger trials and reduce avoidable failures.
Once a tool is qualified, any sponsor can use it within the approved context without needing to re-establish its validity. This accelerates development, encourages innovation and reduces duplication of work.
References
FDA Qualifies First AI Drug Development Tool, Will Be Used in ‘MASH’ Clinical Trials, 08 December 2025, https://www.fda.gov/drugs/drug-safety-and-availability/fda-qualifies-first-ai-drug-development-tool-will-be-used-mash-clinical-trials
Drug Development Tool (DDT) Qualification Programs, 21 July 2025, https://www.fda.gov/drugs/development-approval-process-drugs/drug-development-tool-ddt-qualification-programs
AI-based MASH Scoring, https://www.pathai.com/mash
DDT-BMQ-000105, Artificial Intelligence-Based Histologic Measurement of NASH (AIM-NASH) System, US FDA, https://force-dsc.my.site.com/ddt/s/ddt-project?ddtprojectid=127