Wysa receives FDA Breakthrough Device Designation for its mental health conversational agent

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

Wysa, AI based digital companion for behavioral health, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its AI-based digital mental health conversational agent for patients 18 years and older with a diagnosis of chronic musculoskeletal pain (defined as pain lasting longer than three months) and depression and anxiety.

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 in JMIR, that found Wysa to be effective for managing chronic pain and associated depression and anxiety, which was found to be more effective than standard orthopedic care, and comparable to in-person psychological counseling.

The FDA Breakthrough Device program is designed to help accelerate the development and approval of medical devices and products that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.