Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to Wysa’s AI-based digital mental health chatbot that delivers cognitive-behavioral therapy (CBT) via a smartphone adults suffering from depression, anxiety and chronic musculoskeletal pain.
It is estimated that one in ten people worldwide, or approximately 790 million people worldwide, live with a mental health disorder, according to Our World in Data. Deloitte Global estimates that global spending on mobile mental health apps will reach $500 million in 2022, based on an annual growth rate of around 20%.
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” advisors with master’s degrees in psychology. It is available on Google Play and App Store which applies CBT and other evidence-based techniques in an anonymous and secure platform accessible to users through their smartphones 24/7.
Cognitive-behavioral therapy is a type of psychological treatment based on the fundamental principles that psychological problems are based in part on learned patterns of unhelpful thoughts and behaviors and that people can learn better ways to cope, 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), hypochondriasis, social phobia, low self-esteem, and other mental health issues may benefit from cognitive behavioral therapy, according to Psychology.org.
CEO Jyotsana (Jo) Aggarwal and Chairman Ramakant Vempati co-founded private startup Wysa in 2015 headquartered in Boston, Massachusetts, and venture capital funding from investors such as Google Assistant Investment, among others, according to PitchBook. .
The global artificial intelligence in healthcare market is expected to grow at a compound annual growth rate (CAGR) of 38.4% from 2022 to 2030 to reach $308.2 billion in revenue by 2030, according to Grand View Research. Artificial intelligence (AI) machine learning enables more sophisticated human interactions with chatbots.
According to the FDA, the Breakthrough Devices program aims to enable “rapid access to these medical devices by accelerating their development, evaluation, and review, while preserving legal standards of premarket approval, 510 clearance ( k) and marketing authorization De Novo. , in accordance with the Agency’s mission to protect and promote public health.
Wysa’s admission to the FDA’s Breakthrough Devices Program represents 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 results of the clinical trial were published in a recent study in Human factors theories and frameworks.
Study authors affiliated with Washington University in St Louis School of Medicine in St Louis, Missouri, and Washington University in Seattle, Washington, wrote:
Patients who received a digital mental health intervention as part of orthopedic care reported greater mean improvements over two months in depression, pain interference, and physical function than patients who received usual orthopedic care.
They also reported greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared to orthopedic patients who received in-person psychological counseling.
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