US FDA qualifies first AI tool to help speed liver disease drug development
The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a severe form of fatty liver disease in drug trials, the agency said on Monday.
Now, the tool will be publicly available to be used in any drug development program for the qualified context of use.
The cloud-based system, called AIM-NASH, analyzes images of liver tissue to help doctors assess signs of diseases such as fat buildup, inflammation, and scarring.
The tool is expected to streamline clinical trials for metabolic dysfunction-associated steatohepatitis, or MASH, a condition that affects millions of Americans and can lead to liver failure or cancer, the FDA said.
Currently, multiple experts independently review liver biopsies, a process that is slow and sometimes inconsistent, the agency said, adding that the tool could help standardize the assessment and reduce the time and resources needed to bring new MASH treatments to patients.
Drug developers are increasingly adopting AI technologies, with industry experts predicting such methods could cut development timelines and costs by at least half within three to five years.
AIM-NASH uses AI algorithms to analyze images of liver biopsies and provides scores based on a standard scoring system, which then goes to doctors for final interpretation.
The FDA said the qualification was based on studies showing that AIM-NASH-assisted results were comparable to assessments made by individual experts.
