Boston, MA – December 9, 2025 – PathAI, a global leader in AI-powered pathology, today announced that the U.S. Food and Drug Administration (FDA) has qualified AIM-MASH AI Assist through the Drug Development Tool (DDT) Biomarker Qualification Program (BQP) for use within a context of use (COU) in metabolic dysfunction–associated steatohepatitis (MASH) clinical trials. AIM-MASH AI Assist (formerly known as AIM-NASH before name change in the field) is the first AI-Powered pathology DDT to receive FDA qualification. The qualification follows the European Medicines Agency (EMA) CHMP qualification of AIM-MASH AI Assist earlier this year, underscoring PathAI’s regulatory leadership across both U.S. and European frameworks for AI-assisted histopathology in drug development.
This qualification signifies a major advancement in MASH clinical trials, offering a more efficient, standardized, and reproducible approach to evaluating liver biopsies globally during enrollment and endpoint assessment. 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.
The FDA's DDT program enables biomarkers qualified for a specific context of use to enhance drug development. Per the FDA, drug developers may utilize this DDT for the qualified Context of Use (COU) in investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) submissions, thereby eliminating the need to resubmit DDT information or undergo additional CDER rereview. This is aligned to support the needs of biopsy-based enrollment and endpoint assessment, including for accelerated approval in the U.S., and conditional approval in the EU, in MASH clinical trials. This first-in-class AI-based DDT allows a single pathologist to provide standardized, accurate MASH biopsy assessments at scale.
“Dual qualification by the EMA and the FDA gives sponsors a regulator approved path to use AI-assisted histology for phase 2 and 3 MASH clinical trial enrollment and endpoint assessment. For MASH trials worldwide, that means greater consistency, reproducibility, and confidence in histologic endpoints.” said Naim Alkhouri, MD, FAASLD (Fellow of the American Association for the Study of Liver Diseases)
The FDA qualification builds on an extensive analytical and clinical validation foundation referenced by EMA, which demonstrated non-inferiority to average individual pathologist reads for fibrosis and steatosis, superiority to individual expert manual reads for ballooning, inflammation and clinical trial enrollment and endpoint criteria, and superiority for reproducibility compared to manual reads across every precision metric tested which is one of the key challenges in MASH biopsy scoring for primary endpoint assessment (Pulaski et al., 2025; EMA, 2025). Together, these regulatory milestones deliver an improved path for sponsors to operationalize AI-assisted histology across global MASH drug development programs.
“We’re proud to have worked collaboratively with FDA, EMA, industry partners and advisors to achieve the first FDA and EMA qualification of an AI-based biomarker via their biomarker qualification programs,” said Andy Beck, MD, PhD, Co-founder & CEO of PathAI. “Dual recognition from U.S. and EU regulators underscores our commitment to rigorous validation and responsible deployment of AI to transform pathology and improve patient outcomes.”
AIM-MASH AI Assist Highlights:
- First and only AI-assisted assessment drug development tool qualified by both the FDA and EMA.
- Streamlined reads: As accurate as a consensus of pathologists and more reproducible, AIM-MASH supports a single pathologist in scoring liver biopsies at enrollment and follow-up
- Reproducible and Repeatable Results: AIM-MASH algorithm is 100% repeatable and superior to manual pathologist scoring precision for every metric tested, enabling more accurate assessment of endpoints and response comparison across trials.
- Trial enablement: Supports Phase 2 and Phase 3 MASH clinical trial design strategy, including accurate and efficient enrollment
- Validated performance: Fully analytically and clinically validated with over 1400 clinical trial biopsies to deliver accurate, reliable assessments.
- Secure deployment: Available on the AISight® Clinical Trials Platform for secure, efficient implementation of AIM-MASH AI Assist in a GCP/GCLP compliant manner.
1 AIM-MASH AI Assist is qualified as a tool in the EU and as a DDT in the US for use in MASH clinical trials. AIM-MASH AI Assist is not for use in diagnostic procedures.
References
- Pulaski H, Harrison SA, Mehta SS, Sanyal AJ, Vitali MC, Manigat LC, et al. Clinical validation of an AI-based pathology tool for scoring of metabolic dysfunction-associated steatohepatitis. Nature Medicine. 2025;31:315–322. doi:10.1038/s41591-024-03301-2.
- European Medicines Agency (EMA). Qualification Opinion — Artificial Intelligence-Based Measurement of Non-alcoholic Steatohepatitis Histology in Liver Biopsies to Determine Disease Activity in NASH/MASH Clinical Trials. EMA/CHMP; 2025.
About PathAI
PathAI is a leading provider of AI-powered pathology solutions that aim to improve the accuracy of histology assessment and accelerate drug development. PathAI's platform leverages advanced artificial intelligence to analyze and interpret pathology images, providing valuable insights to pathologists, researchers, and pharmaceutical companies. PathAI is headquartered in Boston, MA. For more information, please visit www.pathai.com and follow us on LinkedIn.
