Mental health AI device receives FDA breakthrough designation

Artificial intelligence-based digital behavioral health companion Wysa was granted breakthrough device designation.

Wysa's conversational agent for patients 18 years and older with chronic musculoskeletal pain, depression and anxiety provides cognitive behavioral therapy via smartphone, the company said May 12.

An earlier peer-reviewed clinical trial published in JMIR Formative Research found Wysa to be effective for managing chronic pain and associated depression and anxiety. It was found to be more effective than standard orthopedic care and comparable to in-person counseling.

The breakthrough device designation is designed to accelerate development and approval.

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