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An Artificial Intelligence Milestone For US FDA

 
• By Ramsey Baghdadi

A project to validate a depression severity measurement tool that employs artificial intelligence for use in drug trials is moving forward at FDA. The milestone is a sign of things to come – and of the incremental process for AI adoption by the regulator.

digital brain waves
• Source: Shutterstock

An automated depression and anxiety severity measurement tool is the first artificial intelligence-based and digital health technology to be accepted into the ISTAND pilot program, the US FDA announced on 23 January.

ISTAND was launched in 2020 and allows sponsors to seek formal FDA qualification for new tools beyond novel biomarkers and...

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