Wysa announced it has received breakthrough device designation from the FDA for its artificial intelligence-based digital mental health conversational agent for adults with chronic musculoskeletal pain, depression and anxiety.
The device delivers cognitive behavioral therapy through a smartphone-based conversational agent, which reduces symptoms of depression and anxiety while also reducing pain interference and improving physical functions.
“We’re thrilled to achieve this meaningful designation from the FDA and look forward to working closely with the agency to continue development