| For the first time since the launch of its launch in 2020 and the start of receiving applications in 2022, the ISTAND program launched by FDA to support non-traditional drug development tools, approved its first tool operating on the basis of artificial intelligence. |
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Deliberate AI’s “System for evaluating clinical results using AI” (AI-COA) has become the first tool to be approved by the FDA through the ISTAND program. The program, which was launched last year, aims to support the development of non-traditional drug development tools.
The AI-COA tool utilizes multimodal processing of behavioral signals and machine learning technology to track symptoms of mental health and assess the severity of anxiety and depression cases. It analyzes various aspects of patients, including facial expressions, speech behavior, physical movements, pupil changes, and vital indicators to provide a quantitative assessment of their mental health.
This technology can be used throughout the clinical testing of new therapeutic agents for depression, anxiety, and neurological conditions. It allows for more accurate monitoring of participants’ progress and the effectiveness of the drugs being tested.
According to Rene Kan, a Doctor of Medical Sciences and Professor of Psychiatry at the Ikana Medical School on Mount Sinai in New York, the inclusion of AI-COA in the ISTAND program represents a significant advancement in psychiatric care. It replaces subjective and time-consuming assessments with a more precise and accurate clinical evaluation and research tool.
Deliberate AI is also working on adapting AI-COA for use in regular clinical and psychotherapeutic assessments. This has the potential to provide a more objective evaluation of patients compared to self-reporting questionnaires.
The FDA introduced the ISTAND program in 2020 to expand the range of tools available to drug manufacturers. The program includes categories such as remote testing tools and non-linear tests using AI algorithms and wearable devices, all aimed at enhancing drug development and understanding.
Integrating AI-COA into medical studies can greatly improve the accuracy of diagnosis and treatment for various diseases, particularly in the field of mental health where