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).

24 devices
  1. 2025-10-21NeuroAlign softwareMedivis, Inc.NeurologyK231897
  2. 2025-10-16Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AGRadiologyK252476
  3. 2025-10-03xvision Spine systemAugmedics, Ltd.NeurologyK251639
  4. 2025-09-29SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK252054
  5. 2025-09-10OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252530
  6. 2025-09-04NextAR(TM) Shoulder PlatformMedacta International S.A.NeurologyK251737
  7. 2025-08-25NeuroEars-Anna™NeuroEars Inc.NeurologyK243709
  8. 2025-08-13RelieVRx (Pico G3)AppliedVRAVRMD record: RelieVRxNeurologyK251519
  9. 2025-08-08OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252170
  10. 2025-07-31NextAR(TM) SpineMedacta International S.A.NeurologyK250477
  11. 2025-07-11Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.CardiovascularK241179
  12. 2025-07-09OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK250108
  13. 2025-07-08ExcelsiusXR™Globus Medical, Inc.NeurologyK241525
  14. 2025-06-27Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)RadiologyK243077
  15. 2025-06-23Digital Prism Correction Feature (DPCF)Apple Inc.AVRMD record: Apple Vision ProOphthalmicK250143
  16. 2025-06-20Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavNeurologyK243053
  17. 2025-05-16Mixed Reality Spine NavigationBrainlab AGNeurologyK242569
  18. 2025-05-02LUMYS (V1)INTRADYSRadiologyK243069
  19. 2025-04-09LuminopiaLuminopia, Inc.OphthalmicK243819
  20. 2025-03-21ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty LimitedNeurologyK243980
  21. 2025-03-20Knee+Pixee MedicalNeurologyK243975
  22. 2025-03-13xvision Spine systemAugmedics Ltd.NeurologyK250255
  23. 2025-01-14SpectoMed (v1.0)Specto MedicalRadiologyK242205
  24. 2025-01-13ARVIS® ShoulderKico Knee Innovation Company Pty LtdNeurologyK243950