Wysa Receives FDA Breakthrough Device Designation For AI-Led Mental Health Conversational Agent

The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation to Wysa for its artificial intelligence (AI) based digital mental health conversational agent for adults with chronic pain and depression and anxiety. The device is intended for adults age 18 and older who have a diagnosis of chronic musculoskeletal pain (defined as pain lasting longer than three months). The device delivers cognitive behavioral therapy (CBT) via a smartphone-based conversational agent to reduce the symptoms of depression and anxiety, reduce pain interference, and improve physical function.

The designation follows an independent peer reviewed clinical trial, published . . .