FDA accepts first AI algorithm to drug development tool pilot, with Deliberate AI’s anxiety and depression assessment

Fierce Biotech January 26, 2024
Andrea Park

For the first time since it launched in 2020 and began accepting submissions in 2022, a program started by the FDA to provide support for unconventional drug development tools has accepted its first artificial intelligence-powered tool.

The Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot was designed to create a new pathway to FDA review for novel tools that may not fit into currently existing routes of evaluation, but that could potentially improve the development of new drugs.

The newest tool accepted into ISTAND comes from Deliberate AI. The AI-generated Clinical Outcome Assessment—AI-COA for short—uses multimodal behavioral signal processing and machine learning technology to record mental health symptoms and assess the severity of cases of anxiety and depression.

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