FDA designates AI-based therapy for pain, depression, anxiety as breakthrough device

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 of AI-based cognitive behavioral therapy,” Jo Aggarwal, Wysa CEO, said in a released statement.

The FDA designation follows an independent, peer-reviewed clinical trial, which showed that the conversational agent was effective for managing chronic pain and associated depression and anxiety. The trial showed it was more effective than standard orthopedic care and comparable to in-person psychological counseling.

“Our mission is to help those in need of support with an always available platform, and during these challenging times it’s more crucial than ever to provide mental health options,” Aggarwal said.