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).

120 devices
  1. 2026-05-27Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)RadiologyK254265
  2. 2026-05-11Pytheas Your Guided TrajectoryPytheas Navigation SasNeurologyK252880
  3. 2026-04-29SCRIPT™ Implant SystemGlobus Medical, Inc.OrthopedicK253401
  4. 2026-04-24Knee+Pixee Medical S.A.S.OrthopedicK253805
  5. 2026-04-10VRNTCognifisense, Inc.NeurologyK254004
  6. 2026-03-30Avatar Medical VisionAvatar MedicalRadiologyK253950
  7. 2026-03-27ARTICOR plannerArtiness S.R.LRadiologyK252195
  8. 2026-02-23SKIA-Head (Model: SKIA-ST00)Skia, Inc.RadiologyK253486
  9. 2026-02-06LAIA XRAugmented Reality Software S.L.RadiologyK251577
  10. 2026-01-29Surgical Reality ViewerMedicalvr B.V.RadiologyK252091
  11. 2026-01-09NextAR Hip PlatformMedacta International S.A.NeurologyK252847
  12. 2025-10-21NeuroAlign softwareMedivis, Inc.NeurologyK231897
  13. 2025-10-16Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AGRadiologyK252476
  14. 2025-10-03xvision Spine systemAugmedics, Ltd.NeurologyK251639
  15. 2025-09-29SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK252054
  16. 2025-09-10OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252530
  17. 2025-09-04NextAR(TM) Shoulder PlatformMedacta International S.A.NeurologyK251737
  18. 2025-08-25NeuroEars-Anna™NeuroEars Inc.NeurologyK243709
  19. 2025-08-13RelieVRx (Pico G3)AppliedVRAVRMD record: RelieVRxNeurologyK251519
  20. 2025-08-08OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK252170
  21. 2025-07-31NextAR(TM) SpineMedacta International S.A.NeurologyK250477
  22. 2025-07-11Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.CardiovascularK241179
  23. 2025-07-09OptiVu™ ShoulderMR Surgical Solutions, LLCNeurologyK250108
  24. 2025-07-08ExcelsiusXR™Globus Medical, Inc.NeurologyK241525
  25. 2025-06-27Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)RadiologyK243077
  26. 2025-06-23Digital Prism Correction Feature (DPCF)Apple Inc.AVRMD record: Apple Vision ProOphthalmicK250143
  27. 2025-06-20Navient Image Guided Navigation System (ENT) (955-NC-NC)ClaronavNeurologyK243053
  28. 2025-05-16Mixed Reality Spine NavigationBrainlab AGNeurologyK242569
  29. 2025-05-02LUMYS (V1)INTRADYSRadiologyK243069
  30. 2025-04-09LuminopiaLuminopia, Inc.OphthalmicK243819
  31. 2025-03-21ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty LimitedNeurologyK243980
  32. 2025-03-20Knee+Pixee MedicalNeurologyK243975
  33. 2025-03-13xvision Spine systemAugmedics Ltd.NeurologyK250255
  34. 2025-01-14SpectoMed (v1.0)Specto MedicalRadiologyK242205
  35. 2025-01-13ARVIS® ShoulderKico Knee Innovation Company Pty LtdNeurologyK243950
  36. 2024-12-24SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK243623
  37. 2024-12-04RelieVRxAppliedVRAVRMD record: RelieVRxNeurologyK243417
  38. 2024-10-30Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyK242271
  39. 2024-10-21Digital Prism Correction Feature (DPCF)Apple Inc.AVRMD record: Apple Vision ProOphthalmicK242058
  40. 2024-10-16xvision Spine SystemAugmedics Ltd.NeurologyK241481
  41. 2024-09-10LumiNE US; LumiAugmedit B.V.RadiologyK240094
  42. 2024-08-19OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.NeurologyK241870
  43. 2024-08-08HipXpert and HipInsight SystemSurgical Planning Associates, IncNeurologyK233315
  44. 2024-07-26Spine Navigation SystemMedivis, Inc.NeurologyK233725
  45. 2024-06-13VERVEOculoMotor TechnologiesOphthalmicK232930
  46. 2024-05-21Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AGRadiologyK232759
  47. 2024-04-24NextAR™ Spine PlatformMedacta International S.A.NeurologyK233172
  48. 2024-03-25Cube NavigatorMedical Templates AGRadiologyK240620
  49. 2024-03-08Neo ADVISE softwareComerge AGNeurologyK230195
  50. 2024-03-08Knee+Pixee MedicalNeurologyK233899
  51. 2024-02-01Augmented Reality ApplicationSira Medical, Inc.RadiologyK232339
  52. 2023-12-05Ceevra Reveal 3+Ceevra, Inc.RadiologyK233568
  53. 2023-11-02STELLAR KneePolarisAR Inc.NeurologyK232176
  54. 2023-10-31VRNTCognifiSense, Inc.NeurologyK230814
  55. 2023-10-29NextAR™ TSA PlatformMedacta International S.A.NeurologyK232280
  56. 2023-10-16IkshanaImmersiveTouchRadiologyK230249
  57. 2023-09-25Smileyscope System (Therapy Mode)Smileyscope Holding Inc.NeurologyK230825
  58. 2023-09-14OrionXRHoth Intelligence Inc.RadiologyK232189
  59. 2023-09-08OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.NeurologyK231284
  60. 2023-08-31HOLO Portal™ Surgical Guidance SystemSurgalign Spine TechnologiesNeurologyK231611
  61. 2023-07-21NextAR™ Spine PlatformMedacta International S.A.NeurologyK223769
  62. 2023-07-14CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)SentiAR, Inc.AVRMD record: SentiARRadiologyK223290
  63. 2023-07-13XR90 (XR90-SYS)MediView XR, Inc.RadiologyK223125
  64. 2023-06-13OptiVu™ ROSA® MxROrthosoft Inc. (d/b/a Zimmer CAS)NeurologyK230567
  65. 2023-05-24Avatar Medical Software V1Avatar MedicalRadiologyK222035
  66. 2023-05-01CarnaLife HoloMedApp S.A.RadiologyK221870
  67. 2023-04-25Ceevra Reveal 3Ceevra, Inc.RadiologyK222676
  68. 2023-04-21Knee+Pixee MedicalNeurologyK230789
  69. 2023-02-24Clarus ViewerClarus Viewer CorporationRadiologyK222757
  70. 2023-01-20Blueprint Mixed Reality systemTornier SASNeurologyK222510
  71. 2022-12-30Cyware 4H and Cysart 4HAbys MedicalRadiologyK221796
  72. 2022-12-16Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyK220554
  73. 2022-11-25VSI HoloMedicineApoQlar GmbHRadiologyK213215
  74. 2022-11-17xvision Spine SystemAugmedics Ltd.NeurologyK220905
  75. 2022-11-04Luminopia OneLuminopia, Inc.OphthalmicK221659
  76. 2022-10-21IntraOp VSP Software DeviceXironetic, LLCRadiologyK213128
  77. 2022-09-29SpineAR SNAPSurgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK213034
  78. 2022-09-01Knee+Pixee MedicalNeurologyK220104
  79. 2022-07-29OptiVu ROSA MxROrthosoft, Inc. (d/b/a Zimmer CAS)RadiologyK220733
  80. 2022-07-12Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker CorporationNeurologyK221098
  81. 2022-06-15SurgiCase ViewerMaterialise NVRadiologyK213684
  82. 2022-05-27VisARNovarad CorporationNeurologyK220146
  83. 2022-03-10NextAR™ TKA Platform My Knee PPSMedacta International S.A.NeurologyK213751
  84. 2022-01-14ARAI Surgical Navigation SystemSurgalign Spine TechnologiesNeurologyK211254
  85. 2021-11-16EaseVRxAppliedVR, Inc.AVRMD record: RelieVRxNeurologyDEN210014
  86. 2021-11-10inVisionOSPrecisionOS Technology Inc.AVRMD record: PrecisionOSRadiologyK210344
  87. 2021-11-05NextAR™ Spine PlatformMedacta International, SANeurologyK210859
  88. 2021-10-20Luminopia OneLuminopia, Inc.OphthalmicDEN210005
  89. 2021-10-02EYE-SYNCSyncThink, Inc.NeurologyK202927
  90. 2021-09-29ImmersiveTouchImmersiveTouch, Inc.RadiologyK210726
  91. 2021-07-19xvision Spine system (XVS)Augmedics LtdNeurologyK211188
  92. 2021-07-14ARVIS Surgical Navigation SystemInsight Medical Systems Inc.NeurologyK203115
  93. 2021-05-14HOLOSCOPE-iReal View Imaging Ltd.RadiologyK210072
  94. 2021-05-12NextAR RSA PlatformMedacta International SANeurologyK210153
  95. 2021-04-21Knee+Pixee MedicalNeurologyK202750
  96. 2021-01-28HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, IncNeurologyK200384
  97. 2020-10-27NextAR TKA PlatformMedacta International SANeurologyK202152
  98. 2020-09-18SentEPSentiAR, IncAVRMD record: SentiARRadiologyK192890
  99. 2020-07-17SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.AVRMD record: Surgical Theater XRRadiologyK201465
  100. 2020-07-10NextAR TKA PlatformMedacta Inernational SAOrthopedicK193559
  101. 2020-01-23Elements ViewerBrainlab AGRadiologyK191014
  102. 2019-12-20xvision Spine system (XVS)Augmedics Ltd.NeurologyK190929
  103. 2019-11-29I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographNeurolign USA, LLCNeurologyK192186
  104. 2019-08-29D2P3D Systems, Inc.RadiologyK183489
  105. 2019-05-13SurgicalARMEDIVIS, Inc.RadiologyK190764
  106. 2019-03-18REAL Immersive SystemPenumbra, Inc.Physical MedicineK183296
  107. 2019-02-22IRIS 1.0 SystemIntuitive SurgicalRadiologyK182643
  108. 2019-02-14Presero 3D Scanning SystemCertis HealthRadiologyK190074
  109. 2018-09-21OpenSightNovarad CorporationRadiologyK172418
  110. 2018-07-10Ceevra Reveal 2.0Ceevra, Inc.RadiologyK173274
  111. 2018-02-12SuRgical Planner (SRP)Surgical Theater, LLCAVRMD record: Surgical Theater XRRadiologyK170793
  112. 2017-08-03Clarity RevealCeevra, Inc.RadiologyK171356
  113. 2017-04-24MindMotionPROMindMaze SAAVRMD record: MindMaze TherapeuticsPhysical MedicineK162748
  114. 2017-03-03True 3D Viewer SoftwareEchoPixel Inc.RadiologyK170167
  115. 2017-02-28Virtual Occupational Therapy Application (VOTA)Barron Associates, Inc.Physical MedicineK163245
  116. 2016-06-28Surgical Navigation Advanced Platform (SNAP)SURGICAL THEATER, LLCAVRMD record: Surgical Theater XRRadiologyK160584
  117. 2016-02-12Clear Guide SCENERGYCLEAR GUIDE MEDICALRadiologyK153004
  118. 2016-02-05YuGo SystemBIOGAMING LTD.Physical MedicineK151955
  119. 2016-01-29EYE-SYNCSyncThink, Inc.NeurologyK152915
  120. 2015-01-21ECHO TRUE 3D VIEWERECHO PIXEL INC.RadiologyK142107