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).

16 devices
  1. 2024-12-24SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK243623
  2. 2024-12-04RelieVRxAppliedVRAVRMD record: RelieVRxNeurologyK243417
  3. 2024-10-30Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyK242271
  4. 2024-10-21Digital Prism Correction Feature (DPCF)Apple Inc.AVRMD record: Apple Vision ProOphthalmicK242058
  5. 2024-10-16xvision Spine SystemAugmedics Ltd.NeurologyK241481
  6. 2024-09-10LumiNE US; LumiAugmedit B.V.RadiologyK240094
  7. 2024-08-19OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.NeurologyK241870
  8. 2024-08-08HipXpert and HipInsight SystemSurgical Planning Associates, IncNeurologyK233315
  9. 2024-07-26Spine Navigation SystemMedivis, Inc.NeurologyK233725
  10. 2024-06-13VERVEOculoMotor TechnologiesOphthalmicK232930
  11. 2024-05-21Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AGRadiologyK232759
  12. 2024-04-24NextAR™ Spine PlatformMedacta International S.A.NeurologyK233172
  13. 2024-03-25Cube NavigatorMedical Templates AGRadiologyK240620
  14. 2024-03-08Neo ADVISE softwareComerge AGNeurologyK230195
  15. 2024-03-08Knee+Pixee MedicalNeurologyK233899
  16. 2024-02-01Augmented Reality ApplicationSira Medical, Inc.RadiologyK232339