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
- 2026-05-11Pytheas Your Guided TrajectoryPytheas Navigation Sas
- 2026-04-10VRNTCognifisense, Inc.
- 2026-01-09NextAR Hip PlatformMedacta International S.A.
- 2025-10-21NeuroAlign softwareMedivis, Inc.
- 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.
- 2025-07-09OptiVu™ ShoulderMR Surgical Solutions, LLC
- 2025-07-08ExcelsiusXR™Globus Medical, Inc.
- 2025-06-20Navient Image Guided Navigation System (ENT) (955-NC-NC)Claronav
- 2025-05-16Mixed Reality Spine NavigationBrainlab AG
- 2025-03-21ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty Limited
- 2025-03-20Knee+Pixee Medical
- 2025-03-13xvision Spine systemAugmedics Ltd.
- 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.
- 2024-10-16xvision Spine SystemAugmedics Ltd.
- 2024-08-19OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.
- 2024-08-08HipXpert and HipInsight SystemSurgical Planning Associates, Inc
- 2024-07-26Spine Navigation SystemMedivis, Inc.
- 2024-04-24NextAR™ Spine PlatformMedacta International S.A.
- 2024-03-08Neo ADVISE softwareComerge AG
- 2024-03-08Knee+Pixee Medical
- 2023-11-02STELLAR KneePolarisAR Inc.
- 2023-10-31VRNTCognifiSense, Inc.
- 2023-10-29NextAR™ TSA PlatformMedacta International S.A.
- 2023-09-25Smileyscope System (Therapy Mode)Smileyscope Holding 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.
- 2023-06-13OptiVu™ ROSA® MxROrthosoft Inc. (d/b/a Zimmer CAS)
- 2023-04-21Knee+Pixee Medical
- 2023-01-20Blueprint Mixed Reality systemTornier SAS
- 2022-12-16Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.
- 2022-11-17xvision Spine SystemAugmedics Ltd.
- 2022-09-29SpineAR SNAPSurgical Theater, Inc.AVRMD record: Surgical Theater XR
- 2022-09-01Knee+Pixee Medical
- 2022-07-12Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation
- 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
- 2021-11-05NextAR™ Spine PlatformMedacta International, SA
- 2021-10-02EYE-SYNCSyncThink, Inc.
- 2021-07-19xvision Spine system (XVS)Augmedics Ltd
- 2021-07-14ARVIS Surgical Navigation SystemInsight Medical Systems Inc.
- 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
- 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
- 2016-01-29EYE-SYNCSyncThink, Inc.