The device delivers cognitive behavioural 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 orthopaedic care and comparable to in-person psychological counselling.
The FDA breakthrough device programme 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.