Wysa Receives FDA Breakthrough Device Designation for AI-led Mental Health Conversational Agent
The FDA Breakthrough Device Designation follows an independent peer-reviewed clinical trial, published in JMIR, that found Wysa to be effective in the management of chronic pain, and associated depression and anxiety. The device was found to be more effective than standard orthopedic care, and comparable to in-person psychological counseling.
Wysa has more than 15 peer-reviewed publications in partnership with academic institutions such as Cambridge University, Harvard University and Washington University of St. Louis amongst others, demonstrating the efficacy of Wysa across multiple clinical concerns. Contact us for the entire list of our publications.
Adherence and Engagement With a Cognitive Behavioral Therapy-Based Conversational Agent (Wysa for Chronic Pain) Among Adults With Chronic Pain: Survival Analysis
Evaluating User Feedback for an Artificial Intelligence-Enabled, Cognitive Behavioral Therapy-Based Mental Health App (Wysa): Qualitative Thematic Analysis
An Empathy-Driven, Conversational Artificial Intelligence Agent (Wysa) for Digital Mental Well-Being: Real-World Data Evaluation Mixed-Methods Study
Understanding People With Chronic Pain Who Use a Cognitive Behavioral Therapy–Based Artificial Intelligence Mental Health App (Wysa): Mixed Methods Retrospective Observational Study
Evaluating the Therapeutic Alliance With a Free-Text CBT Conversational Agent (Wysa): A Mixed-Methods Study
A Digital Mental Health Intervention in an Orthopedic Setting for Patients With Symptoms of Depression and/or Anxiety: Feasibility Prospective Cohort Study
One of our first studies was a real-world mixed methods study on the effectiveness and engagement of Wysa on anonymous global users.
Watch Dr. Becky Inkster talk about the research study published in JMIR mHealth & uHealth.