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).

14 devices
  1. 2022-12-30Cyware 4H and Cysart 4HAbys MedicalRadiologyK221796
  2. 2022-12-16Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyK220554
  3. 2022-11-25VSI HoloMedicineApoQlar GmbHRadiologyK213215
  4. 2022-11-17xvision Spine SystemAugmedics Ltd.NeurologyK220905
  5. 2022-11-04Luminopia OneLuminopia, Inc.OphthalmicK221659
  6. 2022-10-21IntraOp VSP Software DeviceXironetic, LLCRadiologyK213128
  7. 2022-09-29SpineAR SNAPSurgical Theater, Inc.AVRMD record: Surgical Theater XRNeurologyK213034
  8. 2022-09-01Knee+Pixee MedicalNeurologyK220104
  9. 2022-07-29OptiVu ROSA MxROrthosoft, Inc. (d/b/a Zimmer CAS)RadiologyK220733
  10. 2022-07-12Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker CorporationNeurologyK221098
  11. 2022-06-15SurgiCase ViewerMaterialise NVRadiologyK213684
  12. 2022-05-27VisARNovarad CorporationNeurologyK220146
  13. 2022-03-10NextAR™ TKA Platform My Knee PPSMedacta International S.A.NeurologyK213751
  14. 2022-01-14ARAI Surgical Navigation SystemSurgalign Spine TechnologiesNeurologyK211254