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FDA Posts New List of Augmented and Virtual Reality Devices

December 13, 2022

In a nod to the increasing development of three-dimensional visualization tools, the FDA has created a new page on its website devoted to listing augmented and virtual reality medical devices.

The list currently includes 39 devices based on information in their marketing authorization documents, the FDA said.

The new devices can deliver some kinds of non-clinical services in locations where access is often limited, such as at home or other non-clinical settings and make it possible for “underserved communities, the elderly or disabled” to complete treatment and be well monitored from afar, the agency said.

Recently approved devices with these technologies include one that helps women with breast or ovarian cancer have fewer hot flashes, less psychiatric distress and better quality of life, one that takes advanced imaging scans and turns them into 3D holograms for planning complex surgeries, and another that creates a 3D visualization of the ankle joint for total ankle replacement.

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