The device delivers cognitive behavioral therapy 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, which was found to be more effective than standard orthopedic care, and 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 has published peer-reviewed work in the domain of chronic pain which codified user-centric insights, examined the efficacy of the solution in a clinical trial, and future protocols which aim to study this novel solution further in chronic pain.
Wysa is 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, meditation, breathing and mindfulness exercises, as well as micro-actions to help users build mental resilience skills.
Currently, Wysa has facilitated over 400m conversations in 65 countries across the globe.
Wysa works with 20 enterprise partners and 7m 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.
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval