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).
19 devices
- 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