AI-enabled chatbot Wysa receives FDA Breakthrough Device designation for patients with chronic pain, depression and anxiety

AI Behavior Health Chatbot App Fast-Tracked by FDA (Psychology Today): Recently the U.S. Food and Drug Administration (FDA) granted breakthrough device designation to Wysa’s AI-based digital mental health conversational agent that delivers cognitive behavioral therapy (CBT) via a smartphone to adults suffering from depression, anxiety, and chronic musculoskeletal pain… Wysa’s admittance to the FDA Breakthrough Devices Program signifies a giant leap forward for artificial intelligence in the mental health industry. According to the FDA, 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 authors affiliated with the Washington University in St Louis School of Medicine in St Louis, Missouri, and the University of Washington in Seattle, Washington, wrote: Patients who received a digital mental health intervention as part of orthopedic care reported greater two-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care. They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling. The Announcement: Wysa Receives FDA Breakthrough Device Designation for AI-led Mental Health Conversational Agent (press release):...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Technology & Innovation anxiety artificial intelligence CBT chronic musculoskeletal pain cognitive-behavioral-therapy depression digital mental health FDA Food and Drug Administration mental health industry sma Source Type: blogs