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).

11 devices
  1. 2026-05-27Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)RadiologyK254265
  2. 2026-05-11Pytheas Your Guided TrajectoryPytheas Navigation SasNeurologyK252880
  3. 2026-04-29SCRIPT™ Implant SystemGlobus Medical, Inc.OrthopedicK253401
  4. 2026-04-24Knee+Pixee Medical S.A.S.OrthopedicK253805
  5. 2026-04-10VRNTCognifisense, Inc.NeurologyK254004
  6. 2026-03-30Avatar Medical VisionAvatar MedicalRadiologyK253950
  7. 2026-03-27ARTICOR plannerArtiness S.R.LRadiologyK252195
  8. 2026-02-23SKIA-Head (Model: SKIA-ST00)Skia, Inc.RadiologyK253486
  9. 2026-02-06LAIA XRAugmented Reality Software S.L.RadiologyK251577
  10. 2026-01-29Surgical Reality ViewerMedicalvr B.V.RadiologyK252091
  11. 2026-01-09NextAR Hip PlatformMedacta International S.A.NeurologyK252847