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).
24 devices
- 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