An AI company has been granted a special designation for its mental health companion for adults with chronic musculoskeletal pain, depression and anxiety.
Wysa delivers cognitive behavioural therapy (CBT) via a smartphone-based conversational agent to reduce the symptoms of depression and anxiety, reduce pain interference, and improve physical function.
The US Food and Drug Administration (FDA) granted the Breakthrough Device Designation following an independent peer reviewed clinical trial, published in JMIR.
It found Wysa to be effective for managing chronic pain and associated depression and anxiety, which is more effective than standard orthopaedic care, and comparable to in-person psychological counselling.
“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 behavioural therapy,” said Jo Aggarwal, CEO and co-founder of Wysa.
“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.”
The FDA Breakthrough Device programme 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 programme 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.
