The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation to Wysa for its artificial intelligence (AI) based digital mental health conversational agent for adults with chronic pain and depression and anxiety. The device is intended for adults age 18 and older who have a diagnosis of chronic musculoskeletal pain (defined as pain lasting longer than three months). The 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 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. Wysa’s AI device was found to be more effective than standard orthopedic care. Outcomes were comparable to in-person psychological counseling.
The FDA Breakthrough Device program 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. The FDA designation of Wysa’s platform will enable Wysa to efficiently communicate with FDA’s experts through various program options, facilitating the development of the product prior to the premarket review phase.
Wysa is a global leader in AI-driven mental health support, available both to individuals and through employer benefits programs. Wysa is intended to support individuals with the help of an “emotionally intelligent” conversational agent. The bot uses evidence-based cognitive-behavioral techniques (CBT), meditation, breathing and mindfulness exercises, as well as micro-actions to help users build mental resilience skills. For employers, Wysa offers a workplace solution that caters to the full spectrum of mental health needs. This solution embeds into existing company benefits, such as Employee Assistance Programs (EAP) or external health care provider networks, and can be customized by geography or cohort. Currently, Wysa has facilitated over 400 million conversations in 65 countries across the globe. Wysa works with 20 enterprise partners and 7 million employees worldwide, with partners that include Accenture Global, Aetna International, NHS, L’Oreal, Cincinnati Children’s Hospital Medical Center, and the Ministry of Health in Singapore.
This was reported by Wysa on May 12, 2022, at https://www.businesswire.com/news/home/20220512005084/en (accessed May 17, 2022).