Conversational AI Therapy Startup Wysa Earns FDA Breakthrough Certification

Behavioral health conversational AI developer Wysa has scored Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Wysa’s virtual therapist uses cognitive behavioral therapy techniques to help patients with chronic musculoskeletal pain manage depression and anxiety. The FDA bestowed the label following a clinical trial that demonstrated that patients using Wysa managed their pain and mental health as well as those physically visiting real-world therapists.

Wysa Breakthrough

Wysa’s AI therapist interacts via smartphone with patients, engaging with them whenever they wish. The conversational AI employs cognitive behavioral therapy based on the idea that poor but habitual ways of thinking and behaving contribute to psychological problems and that unlearning and replacing those habits can enhance mental health. The AI is supported by human counselors that can pick up the therapy when needed. Wysa users reported that the AI helped them cope with the depression and anxiety that exacerbated their chronic pain. The peer-reviewed clinical trial on Wysa led to the FDA bestowing the Breakthrough Device designation on Wysa. The recognition will help Wysa attain future approval from the FDA as a medical device and opens a channel to the FDA that could speed up market approval.

“We’re thrilled to achieve this meaningful designation from the FDA and look forward to working closely with the Agency to continue the development of AI-based cognitive behavioral therapy,” said Jo Aggarwal, CEO and co-founder of Wysa. “Our mission is to help those in need of support with an always-available platform, and during these challenging times it’s more crucial than ever to provide mental health options.”

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