Regulatory

Every AR/VR device the FDA has authorized.

120 devices from 70 companies, copied from the FDA's own list and checked for changes every day. Each row links to its FDA database record.

This is the regulator's list, shown as published. FDA authorization means a device may be marketed in the US for its stated use; it is not evidence of clinical effectiveness and not an AVRMD endorsement. Source: FDA, Augmented Reality and Virtual Reality Medical Devices (FDA page updated 2026-09-04).

12 devices
  1. 2021-11-16EaseVRxAppliedVR, Inc.AVRMD record: RelieVRxNeurologyDEN210014
  2. 2021-11-10inVisionOSPrecisionOS Technology Inc.AVRMD record: PrecisionOSRadiologyK210344
  3. 2021-11-05NextAR™ Spine PlatformMedacta International, SANeurologyK210859
  4. 2021-10-20Luminopia OneLuminopia, Inc.OphthalmicDEN210005
  5. 2021-10-02EYE-SYNCSyncThink, Inc.NeurologyK202927
  6. 2021-09-29ImmersiveTouchImmersiveTouch, Inc.RadiologyK210726
  7. 2021-07-19xvision Spine system (XVS)Augmedics LtdNeurologyK211188
  8. 2021-07-14ARVIS Surgical Navigation SystemInsight Medical Systems Inc.NeurologyK203115
  9. 2021-05-14HOLOSCOPE-iReal View Imaging Ltd.RadiologyK210072
  10. 2021-05-12NextAR RSA PlatformMedacta International SANeurologyK210153
  11. 2021-04-21Knee+Pixee MedicalNeurologyK202750
  12. 2021-01-28HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, IncNeurologyK200384