US FDA Approved Wysa’s AI Led Device For Mental Health


The Food and Drug Administration (FDA) of the United States has granted approval to a breakthrough device designation of Wysa, an artificial intelligence based platform, for the company’s digital mental health conversational agent based in artificial intelligence for the patients above 18 years along with a diagnosis of the chronic musculoskeletal pain along with depression and anxiety.

The device has also been delivering the cognitive behavioural therapy (CBT) through a conversational agent based on a smartphone for the purpose of decreasing the symptoms of the depression and anxiety, along with the decreasing the pain interference and also improving the physical function.

This designation has been followed by an independent clinical trial peer-reviewed, which has been published and that has found the company ‘Wysa’ for being effective for the purpose of managing the chronic pain and is also associated depression and anxiety, which had been found for being more effective than the standard orthopaedic care and also comparable to the in-person psychological counselling.

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The breakthrough device programme of the US FDA has been designed for helping them to accelerate the development and also approval of the medical devices and the products that are having the potential for providing more effective treatment of the life-threatening diseases or conditions.


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