a digital health technology company that delivers precision measurement of mental health through AI, today announced its inclusion in the U.S. Food and Drug Administration (FDA) Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. Under the program, Deliberate AI’s assessment tool for anxiety and depression, the AI-generated Clinical Outcome Assessment or AI-COA™, will receive support to become a qualified drug development tool (DDT).
The company’s AI-enabled assessment tool leverages cutting-edge multimodal behavioral signal processing and machine learning to quantitatively capture mental health symptoms, offering a consistent, bias-free assessment method. During clinical trials, it augments human clinical assessments with its AI algorithm, to improve precision and reliability. This pivotal endorsement marks Deliberate AI technology as the FDA’s first AI/ML and Digital Health Technology (DHT) initiative, as well as the inaugural project in the fields of Psychiatry and Neuroscience, to join the pilot program. This inclusion underscores the FDA’s commitment to fostering innovative drug development and evaluation solutions, aligning with the agency’s recent discussion paper on leveraging AI and DHT in drug development processes.
“The FDA’s recognition – including Deliberate’s AI-COA™ in this program – heralds a new epoch in developing and monitoring treatments for Depression and Anxiety,” said Marc Aafjes, Founder & CEO of Deliberate AI. “Together, we can pave the way for more powerful, efficient, and faster clinical trials, addressing a critical barrier in psychiatric drug development, ultimately leading to enhanced patient care and a profound public health impact.”
Global experts have also expressed support for Deliberate AI’s innovative approach. “The acceptance by the FDA of AI-COA™ represents a promising advancement in our approach to depression and anxiety trials,” said Dr. Maurizio Fava, Associate Dean for Clinical & Translational Research at Harvard Medical School, Psychiatrist-In-Chief at Mass General, and a leading expert in depression research. “Its pioneering approach and inclusion into the ISTAND program marks a new era in the efficacy measurement of depression therapies.”
Dr. Rene Kahn, Chair of Psychiatry at the Icahn School of Medicine at Mount Sinai and an authority on schizophrenia and psychosis, echoed this sentiment. “The FDA’s inclusion of AI-COA™ into ISTAND is a testament to its potential to revolutionize psychiatric care. Where we have historically relied on subjective and time-consuming assessments, this breakthrough is set to bring unprecedented rigor and precision to clinical assessments and research.”
In addition to its work on clinical trials, Deliberate AI is also focusing on refining AI-COA™ for use in clinical encounters and psychotherapy settings. This enables more precise triage and replaces patient surveys with passive background monitoring for enhanced measurement-based care.
