Wysa Receives FDA Breakthrough Device Designation for AI-led Mental Health Interlocutor

New peer-reviewed studies demonstrate efficacy in managing chronic pain, depression and anxiety

BOSTON, May 12, 2022–(BUSINESS WIRE)–Wysa, a leading artificial intelligence (AI)-based digital companion for behavioral health, announced that the U.S. Food and Drug Administration (FDA) has awarded the Breakthrough Device Designation for its AI-based digital conversation about mental health drug for patients 18 years and older diagnosed with chronic musculoskeletal pain (defined as pain lasting more than three months) and depression and anxiety.

The device delivers cognitive behavioral therapy (CBT) through a smartphone-based conversational tool to reduce symptoms of depression and anxiety, reduce pain interference, and improve physical function.

The designation follows an independent, peer-reviewed clinical study, published in JMIR, which found that Wysa was effective for managing chronic pain and associated depression and anxiety, found to be more effective than standard orthopedic care, and comparable to personal psychological care. coaching. †

“We are excited to receive this meaningful designation from the FDA and look forward to working closely with the Agency to advance the development of AI-based cognitive behavioral therapy,” said Jo Aggarwal, CEO and co-founder of Wysa . “Our mission is to help people in need of support with an always available platform, and in these challenging times it is more important than ever to provide mental health options.”

The FDA Breakthrough Device Program is designed to help accelerate the development and approval of medical devices and products that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA designation of Wysa’s platform allows Wysa to communicate efficiently with FDA experts through a variety of program options, facilitating product development ahead of the premarket assessment phase.

Notes to editors:

Wysa has published peer-reviewed work in the field of chronic pain codifying user-centric insights (link), investigating the efficacy of the solution in a clinical trial (link), and future protocols that aim to further study this novel solution in chronic pain. pain (link).

About Wysa:

Wysa is a global leader in AI-powered mental health, available to individuals as well as through employer benefits programs. Wysa aims to support individuals with the help of an “emotionally intelligent” interlocutor. 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. For employers, Wysa offers a workplace solution that addresses the full spectrum of mental health needs. This solution is integrated into existing business benefits, such as Employee Assistance Programs (EAP) or third-party provider networks, and can be customized by region or cohort. Currently, Wysa has facilitated more than 400 million calls in 65 countries around the world. Wysa works with 20 business partners and 7 million employees worldwide, with partners such as Accenture Global, Aetna International, NHS, L’Oreal, Cincinnati Children’s Hospital Medical Center and the Ministry of Health in Singapore.

Check out the source version at businesswire.com: https://www.businesswire.com/news/home/20220512005084/en/


Sarah Baldry
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+44 (0) 7702 889078

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