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# FDA Qualifies 1st AI Drug Development Tool
- URL: https://www.fdaweb.com/fda-qualifies-1st-ai-drug-development-tool/
- Published: 2025-12-09T12:00:00.000Z
- Updated: 2026-09-14T15:28:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160346

FDA says it has qualified the AI-Based Histologic Measurement of NASH (AIM-NASH), the first artificial intelligence (AI) drug development tool, intended to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials. An agency [announcement](https://force-dsc.my.site.com/ddt/s/ddt-project?ddtprojectid=127&utm%5Fmedium=email&utm%5Fsource=govdelivery) says the cloud-based tool helps pathologists score liver biopsy components, including fat infiltration, inflammation, and scarring.

The agency says that in current MASH clinical trials, multiple experts independently assess liver histology, which the agency describes as a time-consuming process complicated by variable scoring. It says the AI tool could help standardize histologic assessment and reduce the time and resources needed for MASH drug development.

The AI tool uses algorithms to analyze images of liver biopsies and provides scores according to the NASH Clinical Research Network scoring system, FDA says. Humans remain involved in the process, it says, as pathologists are fully responsible for final interpretation, reviewing the whole slide image and AIM-NASH outputs before accepting or rejecting the AI-generated scores.

The qualification was based on comprehensive validation studies, FDA says, demonstrating that AIM-NASH assisted comparisons to expert consensus were similar to individual pathologists’ comparisons to expert consensus.