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
- 2026-05-27Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)
- 2026-05-11Pytheas Your Guided TrajectoryPytheas Navigation Sas
- 2026-04-29SCRIPT™ Implant SystemGlobus Medical, Inc.
- 2026-04-24Knee+Pixee Medical S.A.S.
- 2026-04-10VRNTCognifisense, Inc.
- 2026-03-30Avatar Medical VisionAvatar Medical
- 2026-03-27ARTICOR plannerArtiness S.R.L
- 2026-02-23SKIA-Head (Model: SKIA-ST00)Skia, Inc.
- 2026-02-06LAIA XRAugmented Reality Software S.L.
- 2026-01-29Surgical Reality ViewerMedicalvr B.V.
- 2026-01-09NextAR Hip PlatformMedacta International S.A.
- 2025-10-21NeuroAlign softwareMedivis, Inc.
- 2025-10-16Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AG
- 2025-10-03xvision Spine systemAugmedics, Ltd.
- 2025-09-29SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XR
- 2025-09-10OptiVu™ ShoulderMR Surgical Solutions, LLC
- 2025-09-04NextAR(TM) Shoulder PlatformMedacta International S.A.
- 2025-08-25NeuroEars-Anna™NeuroEars Inc.
- 2025-08-13RelieVRx (Pico G3)AppliedVRAVRMD record: RelieVRx
- 2025-08-08OptiVu™ ShoulderMR Surgical Solutions, LLC
- 2025-07-31NextAR(TM) SpineMedacta International S.A.
- 2025-07-11Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.
- 2025-07-09OptiVu™ ShoulderMR Surgical Solutions, LLC
- 2025-07-08ExcelsiusXR™Globus Medical, Inc.
- 2025-06-27Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- 2025-06-23Digital Prism Correction Feature (DPCF)Apple Inc.AVRMD record: Apple Vision Pro
- 2025-06-20Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav
- 2025-05-16Mixed Reality Spine NavigationBrainlab AG
- 2025-05-02LUMYS (V1)INTRADYS
- 2025-04-09LuminopiaLuminopia, Inc.
- 2025-03-21ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited
- 2025-03-20Knee+Pixee Medical
- 2025-03-13xvision Spine systemAugmedics Ltd.
- 2025-01-14SpectoMed (v1.0)Specto Medical
- 2025-01-13ARVIS® ShoulderKico Knee Innovation Company Pty Ltd
- 2024-12-24SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.AVRMD record: Surgical Theater XR
- 2024-12-04RelieVRxAppliedVRAVRMD record: RelieVRx
- 2024-10-30Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.
- 2024-10-21Digital Prism Correction Feature (DPCF)Apple Inc.AVRMD record: Apple Vision Pro
- 2024-10-16xvision Spine SystemAugmedics Ltd.
- 2024-09-10LumiNE US; LumiAugmedit B.V.
- 2024-08-19OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.
- 2024-08-08HipXpert and HipInsight SystemSurgical Planning Associates, Inc
- 2024-07-26Spine Navigation SystemMedivis, Inc.
- 2024-06-13VERVEOculoMotor Technologies
- 2024-05-21Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AG
- 2024-04-24NextAR™ Spine PlatformMedacta International S.A.
- 2024-03-25Cube NavigatorMedical Templates AG
- 2024-03-08Neo ADVISE softwareComerge AG
- 2024-03-08Knee+Pixee Medical
- 2024-02-01Augmented Reality ApplicationSira Medical, Inc.
- 2023-12-05Ceevra Reveal 3+Ceevra, Inc.
- 2023-11-02STELLAR KneePolarisAR Inc.
- 2023-10-31VRNTCognifiSense, Inc.
- 2023-10-29NextAR™ TSA PlatformMedacta International S.A.
- 2023-10-16IkshanaImmersiveTouch
- 2023-09-25Smileyscope System (Therapy Mode)Smileyscope Holding Inc.
- 2023-09-14OrionXRHoth Intelligence Inc.
- 2023-09-08OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.
- 2023-08-31HOLO Portal™ Surgical Guidance SystemSurgalign Spine Technologies
- 2023-07-21NextAR™ Spine PlatformMedacta International S.A.
- 2023-07-14CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)SentiAR, Inc.AVRMD record: SentiAR
- 2023-07-13XR90 (XR90-SYS)MediView XR, Inc.
- 2023-06-13OptiVu™ ROSA® MxROrthosoft Inc. (d/b/a Zimmer CAS)
- 2023-05-24Avatar Medical Software V1Avatar Medical
- 2023-05-01CarnaLife HoloMedApp S.A.
- 2023-04-25Ceevra Reveal 3Ceevra, Inc.
- 2023-04-21Knee+Pixee Medical
- 2023-02-24Clarus ViewerClarus Viewer Corporation
- 2023-01-20Blueprint Mixed Reality systemTornier SAS
- 2022-12-30Cyware 4H and Cysart 4HAbys Medical
- 2022-12-16Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.
- 2022-11-25VSI HoloMedicineApoQlar GmbH
- 2022-11-17xvision Spine SystemAugmedics Ltd.
- 2022-11-04Luminopia OneLuminopia, Inc.
- 2022-10-21IntraOp VSP Software DeviceXironetic, LLC
- 2022-09-29SpineAR SNAPSurgical Theater, Inc.AVRMD record: Surgical Theater XR
- 2022-09-01Knee+Pixee Medical
- 2022-07-29OptiVu ROSA MxROrthosoft, Inc. (d/b/a Zimmer CAS)
- 2022-07-12Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation
- 2022-06-15SurgiCase ViewerMaterialise NV
- 2022-05-27VisARNovarad Corporation
- 2022-03-10NextAR™ TKA Platform My Knee PPSMedacta International S.A.
- 2022-01-14ARAI Surgical Navigation SystemSurgalign Spine Technologies
- 2021-11-16EaseVRxAppliedVR, Inc.AVRMD record: RelieVRx
- 2021-11-10inVisionOSPrecisionOS Technology Inc.AVRMD record: PrecisionOS
- 2021-11-05NextAR™ Spine PlatformMedacta International, SA
- 2021-10-20Luminopia OneLuminopia, Inc.
- 2021-10-02EYE-SYNCSyncThink, Inc.
- 2021-09-29ImmersiveTouchImmersiveTouch, Inc.
- 2021-07-19xvision Spine system (XVS)Augmedics Ltd
- 2021-07-14ARVIS Surgical Navigation SystemInsight Medical Systems Inc.
- 2021-05-14HOLOSCOPE-iReal View Imaging Ltd.
- 2021-05-12NextAR RSA PlatformMedacta International SA
- 2021-04-21Knee+Pixee Medical
- 2021-01-28HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, Inc
- 2020-10-27NextAR TKA PlatformMedacta International SA
- 2020-09-18SentEPSentiAR, IncAVRMD record: SentiAR
- 2020-07-17SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.AVRMD record: Surgical Theater XR
- 2020-07-10NextAR TKA PlatformMedacta Inernational SA
- 2020-01-23Elements ViewerBrainlab AG
- 2019-12-20xvision Spine system (XVS)Augmedics Ltd.
- 2019-11-29I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographNeurolign USA, LLC
- 2019-08-29D2P3D Systems, Inc.
- 2019-05-13SurgicalARMEDIVIS, Inc.
- 2019-03-18REAL Immersive SystemPenumbra, Inc.
- 2019-02-22IRIS 1.0 SystemIntuitive Surgical
- 2019-02-14Presero 3D Scanning SystemCertis Health
- 2018-09-21OpenSightNovarad Corporation
- 2018-07-10Ceevra Reveal 2.0Ceevra, Inc.
- 2018-02-12SuRgical Planner (SRP)Surgical Theater, LLCAVRMD record: Surgical Theater XR
- 2017-08-03Clarity RevealCeevra, Inc.
- 2017-04-24MindMotionPROMindMaze SAAVRMD record: MindMaze Therapeutics
- 2017-03-03True 3D Viewer SoftwareEchoPixel Inc.
- 2017-02-28Virtual Occupational Therapy Application (VOTA)Barron Associates, Inc.
- 2016-06-28Surgical Navigation Advanced Platform (SNAP)SURGICAL THEATER, LLCAVRMD record: Surgical Theater XR
- 2016-02-12Clear Guide SCENERGYCLEAR GUIDE MEDICAL
- 2016-02-05YuGo SystemBIOGAMING LTD.
- 2016-01-29EYE-SYNCSyncThink, Inc.
- 2015-01-21ECHO TRUE 3D VIEWERECHO PIXEL INC.