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).
46 devices
- 2026-05-27Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)
- 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.
- 2025-10-16Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AG
- 2025-06-27Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- 2025-05-02LUMYS (V1)INTRADYS
- 2025-01-14SpectoMed (v1.0)Specto Medical
- 2024-09-10LumiNE US; LumiAugmedit B.V.
- 2024-05-21Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AG
- 2024-03-25Cube NavigatorMedical Templates AG
- 2024-02-01Augmented Reality ApplicationSira Medical, Inc.
- 2023-12-05Ceevra Reveal 3+Ceevra, Inc.
- 2023-10-16IkshanaImmersiveTouch
- 2023-09-14OrionXRHoth Intelligence Inc.
- 2023-07-14CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)SentiAR, Inc.AVRMD record: SentiAR
- 2023-07-13XR90 (XR90-SYS)MediView XR, Inc.
- 2023-05-24Avatar Medical Software V1Avatar Medical
- 2023-05-01CarnaLife HoloMedApp S.A.
- 2023-04-25Ceevra Reveal 3Ceevra, Inc.
- 2023-02-24Clarus ViewerClarus Viewer Corporation
- 2022-12-30Cyware 4H and Cysart 4HAbys Medical
- 2022-11-25VSI HoloMedicineApoQlar GmbH
- 2022-10-21IntraOp VSP Software DeviceXironetic, LLC
- 2022-07-29OptiVu ROSA MxROrthosoft, Inc. (d/b/a Zimmer CAS)
- 2022-06-15SurgiCase ViewerMaterialise NV
- 2021-11-10inVisionOSPrecisionOS Technology Inc.AVRMD record: PrecisionOS
- 2021-09-29ImmersiveTouchImmersiveTouch, Inc.
- 2021-05-14HOLOSCOPE-iReal View Imaging Ltd.
- 2020-09-18SentEPSentiAR, IncAVRMD record: SentiAR
- 2020-07-17SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.AVRMD record: Surgical Theater XR
- 2020-01-23Elements ViewerBrainlab AG
- 2019-08-29D2P3D Systems, Inc.
- 2019-05-13SurgicalARMEDIVIS, 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.
- 2017-03-03True 3D Viewer SoftwareEchoPixel Inc.
- 2016-06-28Surgical Navigation Advanced Platform (SNAP)SURGICAL THEATER, LLCAVRMD record: Surgical Theater XR
- 2016-02-12Clear Guide SCENERGYCLEAR GUIDE MEDICAL
- 2015-01-21ECHO TRUE 3D VIEWERECHO PIXEL INC.