VR therapy and the FDA: what has actually been cleared, and what it means for rehabilitation

Why VR became medicine

Virtual reality does something no screen can: it replaces the patient's surroundings. That single property explains almost every therapeutic use the FDA has reviewed so far.

• Attention. An immersive world competes with pain signals for the brain's limited attention. This is the basis of VR for procedural pain.
• Skills practice. Breathing, relaxation and cognitive behavioral techniques can be taught inside a calm, guided environment, and repeated at home.
• Dosed, repeatable exercise. Movements and tasks can be graded in difficulty and repeated hundreds of times, which is what recovery after stroke and brain injury needs.
• Measurement. A headset tracks every movement and response. Therapy becomes a source of data, not only a service.

Regulators care about one question above all: does the device do what its label says, safely, for the people it is meant for? The answer has to be specific. That is why every VR clearance so far is narrow: one condition, one age group, one setting.

Cleared, granted, approved: the words matter

The FDA sorts medical devices into three risk classes and offers three main routes to the U.S. market. Using the wrong word is not a style issue. Calling a cleared device "FDA approved" misstates its status.

Two more terms often cause confusion:

• Breakthrough Device designation is a faster, more interactive review process for promising technologies. It is not a marketing authorization. EaseVRx received it in 2020, a year before its De Novo grant. Floreo, a VR program for social and behavioral skills in autism, also holds the designation.
• "FDA registered" usually means the company registered its establishment and listed its product. That is an administrative step. It is not a review of safety or effectiveness.

Every milestone, 2017 to 2025

The path from rehabilitation tools to prescribed therapies, in the order it happened.

1. 2017
   MindMotion PROMindMaze · 510(k)

   Immersive upper-limb neurorehabilitation for early care in the hospital.

2. May 2018
   MindMotion GOMindMaze · 510(k) K173931

   Motor rehabilitation for adults with mild to moderate neurological impairment, in the clinic and at home.

3. Mar 2019
   REAL Immersive SystemPenumbra · 510(k) K183296

   Seated upper-extremity rehabilitation exercises in clinics, under a trained professional's supervision.

4. Oct 2021
   LuminopiaLuminopia · De Novo

   The first VR therapy for amblyopia, for children aged 4 to 7. It created a new device type for digital amblyopia therapy.

5. Nov 2021
   EaseVRx, later RelieVRxAppliedVR · De Novo DEN210014

   The first VR therapy for chronic low back pain. It created a new device type: 21 CFR 890.5800, "virtual reality behavioral therapy device for pain relief."

6. Apr 2023
   HCPCS code E1905CMS

   The first billing code for a VR therapy, describing a "virtual reality cognitive behavior therapy device."

7. Sep 2023
   SmileyscopeSmileyscope · 510(k) K230825

   Pain and anxiety relief during needle procedures for children aged 4 to 11, with EaseVRx as the predicate.

8. Oct 2023
   VRNTCognifiSense · 510(k) K230814

   A second home VR therapy for chronic low back pain, under the same new classification.

9. Nov 2024
   First Digital Health Advisory CommitteeFDA

   The FDA's new expert panel met for the first time, on generative AI in medical devices.

10. Dec 2024
    RelieVRx on a new headsetAppliedVR · 510(k) K243417

    A hardware and software update cleared by comparing it with the original device.

11. Apr 2025
    Luminopia, ages 8 to 12Luminopia · 510(k)

    The label was extended to older children, based on real-world evidence from the company's patient registry.

12. Jun 2025
    Cochrane review update190 trials · 7,188 people

    The largest synthesis of VR for stroke rehabilitation to date.

13. Jul 2025
    92 AR and VR devicesFDA list

    The FDA's public list of AR and VR medical devices reached 92 entries.

The devices, one by one

Chronic painRelieVRx (formerly EaseVRx), AppliedVR

An eight-week, at-home program of short daily sessions that teach pain-management skills based on cognitive behavioral therapy, for adults with chronic low back pain. It is prescription-only and used alongside other care.

In the pivotal randomized, double-blind trial of 179 adults, 66% of people using the VR program reported more than a 30% reduction in pain at the end of treatment, compared with 41% in the control group. No serious adverse events were reported. About one in five participants reported headset discomfort, and close to one in ten reported motion sickness or nausea.

The FDA placed it in Class II with special controls: clinical performance testing that validates the behavioral therapy as the device delivers it, plus an evaluation of all adverse events. That rule now applies to every VR pain-relief device that follows.

Chronic painVRNT, CognifiSense

Cleared in October 2023 for the same population: adults with moderate to severe chronic low back pain lasting more than three months, at home, to reduce pain and pain interference. It shows how a De Novo grant opens the door for competitors.

Pediatric proceduresSmileyscope

For children aged 4 to 11 during needle procedures such as blood draws, IV placement and vaccinations. Its "procedural choreography" matches what the child sees in VR to what happens to their body, so the needle itself becomes a friendly fish in the virtual world. It is cleared to temporarily reduce pain and procedural anxiety, and it is explicitly not intended to treat anxiety disorders or needle phobia.

VisionLuminopia

Children with amblyopia ("lazy eye") watch TV shows in a headset for one hour a day, six days a week. The software adjusts the image for each eye so that both eyes have to work together. It is used together with glasses. It was granted in October 2021 for ages 4 to 7 after a randomized trial of 105 children, and extended to ages 8 to 12 in April 2025.

NeurorehabilitationMindMotion PRO and GO, MindMaze

Among the earliest VR rehabilitation devices on the U.S. market. Both are Class II "interactive rehabilitation exercise devices" cleared through 510(k). PRO targets severe impairment and early hospital care. GO, cleared in 2018, supports adults with mild to moderate impairment, with real-time feedback that helps therapists adjust the program.

NeurorehabilitationREAL Immersive System, Penumbra

Cleared in 2019 for upper-extremity rehabilitation exercises in adults, done seated in a clinic under a trained professional's supervision. Its clearance rested mainly on non-clinical testing, with MindMotion PRO as the predicate.

A pattern worth noticing: the rehabilitation devices were cleared as exercise and measurement tools through 510(k), largely on engineering evidence. The pain and vision therapies made therapeutic claims, so they needed new classifications backed by randomized trials.

What the evidence says

Regulatory decisions cover single products. The wider question is whether VR rehabilitation works as a category. For stroke, the clearest answer comes from the Cochrane review updated in June 2025. It pooled 190 randomized trials with 7,188 adults after stroke.

• Used instead of another therapy, VR gave a slight improvement in arm function (low-certainty evidence).
• Used in addition to usual care, so that patients got more total therapy time, the benefit roughly doubled (moderate-certainty evidence).
• Balance improved slightly. Effects on walking, participation and quality of life remain uncertain.
• No serious adverse effects were reported. A few participants had mild pain, headache or dizziness.

The message for clinics is practical. VR earns its place by adding high-quality practice time that a therapist alone cannot provide, not by replacing the therapist. Critics also note that many trials were small and used basic, low-cost systems. Better-designed, well-measured studies are still needed, and that is an opportunity.

Clearance is not payment

An FDA decision lets a device be sold. It does not make anyone pay for it. In April 2023, the U.S. Centers for Medicare & Medicaid Services created HCPCS code E1905 for RelieVRx: the first billing code for a VR therapy, placed in the durable medical equipment benefit category.

Even then, CMS did not set a national price or mandate coverage. Regional Medicare contractors decide claim by claim. The lesson for every VR company: plan the evidence for payers as early as the evidence for regulators. Payers ask a different question. Not "is it safe and effective?" but "is it worth paying for, compared with what we already pay for?"

VR meets AI: the next regulatory frontier

The next generation of VR therapy will adapt to each patient in real time, and some of it will talk back. Regulators are preparing. In November 2024, the FDA's new Digital Health Advisory Committee held its first meeting, on generative AI in medical devices. In November 2025 it met again, this time on generative AI in digital mental health devices. By then the FDA had authorized more than 1,200 AI-enabled devices, and none of them used generative AI for mental health conditions.

Two themes run through the discussion and matter for VR: how to evaluate a system that changes as it learns, and how to monitor it after launch. Products that already capture rich, structured outcome data from every session start with a large advantage.

Eight lessons for rehabilitation

1. The indication is the product. Condition, age range, setting and whether the device is adjunctive are all written into the label. Every clearance above is specific.
2. Adjunctive beats replacement. Most VR therapies are cleared as an add-on to standard care, which matches the stroke evidence.
3. Therapeutic claims need trials. Exercise and measurement tools were cleared largely on engineering evidence. Claims to reduce pain or improve vision required randomized trials.
4. Adverse events are part of the evidence. Headset discomfort and motion sickness are measured and reported, not ignored.
5. First movers set the rules. A De Novo grant creates special controls that every follower must meet, and makes the follower's 510(k) faster.
6. Real-world data can grow a label. Luminopia's 2025 expansion used registry evidence from everyday use.
7. Hardware is part of the device. Moving to a new headset meant a new submission for RelieVRx.
8. Payment is a separate project. A billing code took more than a year after authorization, and it still did not set a price.

A checklist for clinics evaluating VR

• Ask for the exact regulatory status in your country and, for the U.S., the 510(k) or De Novo number. Then look it up in the FDA's public database.
• Read the indication: does it cover your patients, their age and your setting (clinic or home)?
• Ask what outcomes the system measures, and whether you can see and export them for your own records.
• Check where patient data is stored and who can access it.
• Ask how the system handles cybersickness, seated use and wheelchair users.
• Plan how VR will add practice time, not just replace existing therapy.