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FDA: Augmented Reality and Virtual Reality in Medical Devices

The FDA has reviewed and authorized for marketing a growing number of devices through 510(k) clearance, granted De Novo request, or Premarket Approval with AR/VR across many different fields of medicine—and expects this trend to continue.

The FDA is providing this list of medical devices that incorporate AR/VR marketed in the United States as a resource to the public about these devices and the FDA’s work in this area.


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