The device delivers Cognitive behavioral therapy (CBT) Via a smartphone-based communication agent to reduce symptoms of depression and anxiety, reduce pain interruptions, and improve physical function.
This designation follows an independent peer-reviewed clinical trial, which is published in JMIRIn which Vaisa was found to be effective for the management of chronic pain and associated depression and anxiety, which was found to be more effective than standard orthopedic care and comparable to individual 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.
