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 . . .
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