FDA accepts 1st AI-based tool into Istand pilot program

Computer Brain Hemisphere Social

A mental health assessment tool enabled by artificial intelligence (AI) has become the first AI-powered tool to be accepted into the U.S. Food and Drug Administration’s (FDA) Innovative Science and Technology Approaches for New Drugs (Istand) pilot program for advancing drug development.

As part of the Istand program, digital health company Deliberate AI’s AI-generated clinical outcome assessment (AI-COA) tool for anxiety and depression will receive support to become a qualified drug development tool (DDT).

Launched in 2020, Istand was initiated to provide support for unconventional DDTs -- those that the FDA says “do not fit into established pathways for evaluation and application such as for biomarkers and clinical outcome assessments.”

Not only is AI-COA the first AI-powered DDT that the program has accepted since it began accepting submissions in 2022, but it is also Istand’s first digital health technology-based project and its first project in neuroscience, according to the FDA.

AI-COA uses multimodal behavioral signal processing and machine learning to quantitatively capture mental health symptoms and offer a consistent, bias-free assessment, Deliberate AI said in a statement. Additionally, it is designed to augment human clinical assessments to improve precision and reliability during clinical trials.

The firm says that it is also focusing on expanding AI-COA’s use beyond clinical trials to refine it for use in clinical and psychotherapy settings. 

Page 1 of 5
Next Page