On November 16, 2021, the Food & Drug Administration (FDA) authorized marketing of a prescription-use immersive virtual reality (VR) system for reduction of chronic back pain. Called EaseVRx, the VR system includes a prescription device consisting of a VR headset and controller and a breathing amplifier for use in deep breathing exercises, along with a treatment program consisting of 56 VR sessions. The program uses cognitive behavioral therapy to aid in pain relief through relaxation and other techniques. EaseVRx was granted approval through the De Novo premarket review pathway and was designated as a Breakthrough Device.

The FDA evaluated the safety and effectiveness of EaseVRx based on results of a randomized double-blinded clinical trial. Participants using EaseVRx reported greater reduction in pain than a control group using a 2-D program and no serious adverse events were observed.

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