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FDA Approves First Virtual Reality Device for Chronic Low Back Pain — Pain News Network

EaseVRx was given a Breakthrough Device Designation by the FDA in 2020 for treating fibromyalgia and chronic lower back pain. The designation speeds up the development and review of new medical devices.

Marketing approval of EaseVRx – known as a “De Novo pre-market review” – creates a new regulatory classification for VR devices. It clears the way for similar devices with the same intended use to obtain marketing authorization – a significant development for the fledgling virtual reality industry.

“We worked tirelessly over the past few years to build an unmatched body of clinical evidence that demonstrates the power of VR for the treatment of pain, and couldn’t be more thrilled to achieve this important milestone,” said Josh Sackman, AppliedVR’s co-founder and president. “But, our mission does not stop with this one approval. We’re committed to continuing research that validates our efficacy and cost-effectiveness for treating chronic pain and other indications.”

EaseVRx will only be available by prescription. Its software programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery.  The content also incorporates biopsychosocial pain education, diaphragmatic breathing, mindfulness, and relaxation exercises.

AppliedVR headsets are already being used for pain management in over 200 hospitals and healthcare systems. The company has yet to announce plans for a full consumer rollout of EaseVRx.


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