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).

60 devices
  1. 2026-05-11Pytheas Your Guided TrajectoryPytheas Navigation SasNeurologyK252880
  2. 2026-04-10VRNTCognifisense, Inc.NeurologyK254004
  3. 2026-01-09NextAR Hip PlatformMedacta International S.A.NeurologyK252847
  4. 2025-10-21NeuroAlign softwareMedivis, Inc.NeurologyK231897
  5. 2025-10-03xvision Spine systemAugmedics, Ltd.NeurologyK251639
  6. 2025-09-29SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK252054
  7. 2025-09-10OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252530
  8. 2025-09-04NextAR(TM) Shoulder PlatformMedacta International S.A.NeurologyK251737
  9. 2025-08-25NeuroEars-Anna™NeuroEars Inc.NeurologyK243709
  10. 2025-08-13RelieVRx (Pico G3)AppliedVRAVRMD record: RelieVRxNeurologyK251519
  11. 2025-08-08OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252170
  12. 2025-07-31NextAR(TM) SpineMedacta International S.A.NeurologyK250477
  13. 2025-07-09OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK250108
  14. 2025-07-08ExcelsiusXR™Globus Medical, Inc.NeurologyK241525
  15. 2025-06-20Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavNeurologyK243053
  16. 2025-05-16Mixed Reality Spine NavigationBrainlab AGNeurologyK242569
  17. 2025-03-21ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty LimitedNeurologyK243980
  18. 2025-03-20Knee+Pixee MedicalNeurologyK243975
  19. 2025-03-13xvision Spine systemAugmedics Ltd.NeurologyK250255
  20. 2025-01-13ARVIS® ShoulderKico Knee Innovation Company Pty LtdNeurologyK243950
  21. 2024-12-24SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK243623
  22. 2024-12-04RelieVRxAppliedVRAVRMD record: RelieVRxNeurologyK243417
  23. 2024-10-30Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyK242271
  24. 2024-10-16xvision Spine SystemAugmedics Ltd.NeurologyK241481
  25. 2024-08-19OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.NeurologyK241870
  26. 2024-08-08HipXpert and HipInsight SystemSurgical Planning Associates, IncNeurologyK233315
  27. 2024-07-26Spine Navigation SystemMedivis, Inc.NeurologyK233725
  28. 2024-04-24NextAR™ Spine PlatformMedacta International S.A.NeurologyK233172
  29. 2024-03-08Neo ADVISE softwareComerge AGNeurologyK230195
  30. 2024-03-08Knee+Pixee MedicalNeurologyK233899
  31. 2023-11-02STELLAR KneePolarisAR Inc.NeurologyK232176
  32. 2023-10-31VRNTCognifiSense, Inc.NeurologyK230814
  33. 2023-10-29NextAR™ TSA PlatformMedacta International S.A.NeurologyK232280
  34. 2023-09-25Smileyscope System (Therapy Mode)Smileyscope Holding Inc.NeurologyK230825
  35. 2023-09-08OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.NeurologyK231284
  36. 2023-08-31HOLO Portal™ Surgical Guidance SystemSurgalign Spine TechnologiesNeurologyK231611
  37. 2023-07-21NextAR™ Spine PlatformMedacta International S.A.NeurologyK223769
  38. 2023-06-13OptiVu™ ROSA® MxROrthosoft Inc. (d/b/a Zimmer CAS)NeurologyK230567
  39. 2023-04-21Knee+Pixee MedicalNeurologyK230789
  40. 2023-01-20Blueprint Mixed Reality systemTornier SASNeurologyK222510
  41. 2022-12-16Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyK220554
  42. 2022-11-17xvision Spine SystemAugmedics Ltd.NeurologyK220905
  43. 2022-09-29SpineAR SNAPSurgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK213034
  44. 2022-09-01Knee+Pixee MedicalNeurologyK220104
  45. 2022-07-12Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker CorporationNeurologyK221098
  46. 2022-05-27VisARNovarad CorporationNeurologyK220146
  47. 2022-03-10NextAR™ TKA Platform My Knee PPSMedacta International S.A.NeurologyK213751
  48. 2022-01-14ARAI Surgical Navigation SystemSurgalign Spine TechnologiesNeurologyK211254
  49. 2021-11-16EaseVRxAppliedVR, Inc.AVRMD record: RelieVRxNeurologyDEN210014
  50. 2021-11-05NextAR™ Spine PlatformMedacta International, SANeurologyK210859
  51. 2021-10-02EYE-SYNCSyncThink, Inc.NeurologyK202927
  52. 2021-07-19xvision Spine system (XVS)Augmedics LtdNeurologyK211188
  53. 2021-07-14ARVIS Surgical Navigation SystemInsight Medical Systems Inc.NeurologyK203115
  54. 2021-05-12NextAR RSA PlatformMedacta International SANeurologyK210153
  55. 2021-04-21Knee+Pixee MedicalNeurologyK202750
  56. 2021-01-28HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, IncNeurologyK200384
  57. 2020-10-27NextAR TKA PlatformMedacta International SANeurologyK202152
  58. 2019-12-20xvision Spine system (XVS)Augmedics Ltd.NeurologyK190929
  59. 2019-11-29I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographNeurolign USA, LLCNeurologyK192186
  60. 2016-01-29EYE-SYNCSyncThink, Inc.NeurologyK152915