Wysa’s App For Adults With Chronic Pain Receives FDA Breakthrough Device Designation

On May 12, 2022, Wysa announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to its artificial intelligence (AI)-based cognitive behavioral therapy (CBT) app for adults with chronic musculoskeletal pain, who also have depression and/or anxiety. Chronic musculoskeletal pain is defined as pain lasting longer than three months.

Wysa is a commercially available digital mental health intervention that delivers CBT via a smartphone-based conversational agent to reduce the symptoms of depression and anxiety, reduce pain interference, and improve physical function. It provides a multicomponent intervention that uses AI–based chatbot technology and . . .