FDA Grants AppliedVR Approval For First Virtual Reality Therapeutic To Treat Chronic Low Back Pain

The U.S. Food and Drug Administration (FDA) authorized marketing of EaseVRx, a prescription-use immersive virtual reality (VR) system that uses cognitive behavioral therapy (CBT) and other behavioral methods to help with pain reduction in users 18 years of age and older with diagnosed chronic lower back pain. The FDA approved EaseVRx as a Class II medical device. EaseVRx is manufactured by AppliedVR. The system is intended for home use.

The EaseVRx system includes a VR headset and a controller, along with a “Breathing Amplifier” attached to the headset that directs the user’s breath toward the headset’s . . .