Wysa’s AI Mental Health Software Designated an FDA Breakthrough Device

Boston, Mass.-based Wysa’s artificial intelligence (AI) mental health software has been granted an FDA Breakthrough Device designation.

The Wysa software-as-a-medical-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 was supported by a clinical trial that found Wysa to be more effective than standard orthopedic care and comparable to in-person psychological counseling. The study findings, reported in the journal Theories and Frameworks in Human Factors, indicate “the lack of support structures and suggest that Wysa can provide effective support to bridge the gap,” the company said.