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The First VR Device to Get an FDA Designation for Treating Acute Pain

AppliedVR recently made an announcement about its EaseVRx headset. The Food and Drug Administration (FDA) has given Breakthrough Device Designation to the Los Angeles-based VR firm’s product. Now, AppliedVR can use its EaseVRx headset for treating chronic intractable lower back pain and fibromyalgia. It is the first virtual reality gadget to receive the FDA’s Breakthrough Designation for dealing with a severe pain condition.

The designation boosts the development and review of unique medical devices that deal with irreversibly debilitating or life-threatening conditions or diseases. EaseVRx’s designation can also enhance insurance coverage of virtual reality therapy for extreme pain.

Therapeutic potential

Matthew Stoudt, AppliedVR’s CEO, talked about his company and portrayed it as the most evidence-backed virtual reality platform available on the market. Stoudt, also the firm’s co-founder, then mentioned that health professionals across the spectrum understand virtual reality’s therapeutic potential as an effective pain treatment.

Believe, want, embrace

With the Corona pandemic immensely disrupting people’s abilities to get safe in-person care, AppliedVR is looking forward to offering EaseVRx to those who are suffering from pain. Stoudt said that providers believe in the device, patients want it, and payers are embracing it.

Clinical trial

The company funded a clinical trial that showcased virtual reality therapy can be self-administered at home to take care of severe pain. People suffering from chronic lower back pain or fibromyalgia got virtual reality headsets and were instructed to view a minimum of one VR program regularly for 21 days.

The First VR Device to Get an FDA Designation for Treating Acute Pain

These programs take users in a “digital” environment where they can engage in multiple activities like playing games, swimming with dolphins, or enjoying striking imagery. The programs’ goal is to support patients and help them learn ways to counter their pain and other symptoms. It will be done by distracting them so that their pain seems less vital.

In the end, 84 percent of people were pleased with the virtual reality therapy. Their pain intensity lowered by an average of 30 percent. Additionally, mood, physical activity, stress, and sleep levels also improved.

Behavioral medicine

Beth Darnall, AppliedVR’s chief science advisor, described VR as a potential skills-based behavioral medicine that is known for high patient engagement and satisfaction. Till now, chronic pain patients have had limited access to virtual reality. So, they are excited to work with the FDA to create their platform and bring it to the market quickly.


Madora Pennington, a PNN columnist, lives with Ehlers-Danlos Syndrome’s severe pain. She recently reviewed one of the virtual reality headsets and said that viewing virtual reality programs helped calm her.

Madora wrote that VR therapy’s benefits stayed with her even after the sessions ended. After some weeks of virtual reality, during a meeting with a physical therapist, she noticed that she was no more afraid of the therapist touching her back and neck. Numerous hospitals are using AppliedVR’s technology, but the devices are currently unavailable for home use. The firm is working with Cleveland Clinic and Geisinger Health in two studies. The objective is to witness if virtual reality therapy will be helpful as an opioid-sparing tool for chronic and acute pain.

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