Pathology infrastructure and analysis tools
PathAI develops AI tools for pathology, biomarker work and drug development. Its AISight platform manages images and cases, while individual algorithms address particular analysis tasks. The status of a viewing platform should be distinguished from authorization or qualification of an algorithm. [1]
A defined use in liver-disease trials
FDA qualified AIM-NASH in December 2025 to assist histologic assessment in MASH clinical trials. PathAI calls the product AIM-MASH AI Assist and identifies AIM-NASH as its earlier name. It helps score features of liver biopsy images within a specified context of use. [2][3]
The pathologist remains responsible
FDA says pathologists review the slide and model outputs and retain responsibility for accepting or rejecting the scores. Qualification supports use of the tool in drug development; it is not a general diagnostic approval, an authorization for autonomous pathology or approval of a medicine studied with it. [2][3]
Sources
- PathAI | Pathology Transformed
PathAI · retrieved Oct 23, 2026
- FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials
FDA · Dec 8, 2025
- PathAI’s AIM-MASH AI Assist Becomes First AI-Powered Tool to Receive FDA Qualification for MASH Clinical Trials
PathAI · Dec 9, 2025