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AI Behavior Health Chatbot App Fast-Tracked by FDA

Wysa AI for depression, pain, and anxiety wins FDA breakthrough designation.

Key points

  • The FDA approved an AI-based digital mental health conversational agent that delivers cognitive behavioral therapy (CBT) via a smartphone.
  • Worldwide spending on mobile mental health applications is estimated to reach USD 500 million in 2022.
  • The FDA supported the designation with a clinical trial that found the technology comparable to in-person psychological counseling.
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Recently the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to Wysa’s AI-based digital mental health conversational agent that delivers cognitive behavioral therapy (CBT) via a smartphone to adults suffering from depression, anxiety, and chronic musculoskeletal pain.

An estimated one in ten people globally, which is roughly over 790 million people worldwide, live with a mental health disorder, according to Our World in Data. Deloitte Global estimates worldwide spending on mobile mental health applications will reach USD 500 million in 2022, based on an annual growth rate of roughly 20 percent.

Wysa is based on cognitive-behavioral therapy, motivational interviewing, and mindfulness principles. Wysa is an AI chatbot conversational agent that also provides access to human “coach” counselors who have master’s degrees in psychology. It is available on Google Play and App Store that applies CBT and other evidence-based techniques in an anonymous, secure platform accessible to users via their smartphones 24x7.

Cognitive-behavioral therapy is a type of psychological treatment based on the core principles that psychological problems are based in part on learned patterns of unhelpful thinking and behavior and that people can learn better ways of coping, according to the American Psychological Association (APA).

According to the APA, CBT is a common type of psychotherapy and is often used as a first-line treatment by psychologists for people with anxiety, depression, and post-traumatic stress disorder (PTSD). Additionally, patients with paranoia, phobias, bipolar disorder, schizophrenia, obsessive-compulsive disorder (OCD), hypochondria, social phobia, low self-esteem, and other mental health challenges may benefit from cognitive behavioral therapy, according to

CEO Jyotsana (Jo) Aggarwal and President Ramakant Vempati co-founded privately-held startup Wysa in 2015 with headquarters in Boston, Massachusetts, and venture funding from investors such as Google Assistant Investment, among others, according to PitchBook.

The worldwide market for artificial intelligence in healthcare is expected to grow at a compound annual growth rate (CAGR) of 38.4 percent from 2022 to 2030 to reach USD 308.2 billion in revenues by 2030, according to Grand View Research. Artificial intelligence (AI) machine learning enables more sophisticated human interactions with conversational agents.

According to the FDA, the Breakthrough Devices Program aims to enable “timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.”

Wysa’s admittance to the FDA Breakthrough Devices Program signifies a giant leap forward for artificial intelligence in the mental health industry. According to the FDA, the designation was supported by a clinical trial that “found Wysa to be more effective than standard orthopedic care and comparable to in-person psychological counseling.” The clinical trial results were published in a recent study in Theories and Frameworks in Human Factors.

The study authors affiliated with the Washington University in St Louis School of Medicine in St Louis, Missouri, and the University of Washington in Seattle, Washington, wrote:

Patients who received a digital mental health intervention as part of orthopedic care reported greater two-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care.

They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling.

Copyright © 2022 Cami Rosso. All rights reserved.

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