Radiology Business September 11, 2024
The U.S. Food and Drug Administration on Sept. 6 updated its list of cleared devices that utilize augmented or virtual reality, with radiology leading among other specialties.
As of this month, the FDA has now authorized a total of 69 medical products that incorporate AR/VR. One of the latest is Germany-based vendor Brainlab’s Elements Viewer, which earned 510(k) clearance in May. The product incorporates radiological data, allowing users to wear mixed-reality glasses and manipulate medical images.
“The FDA has reviewed and authorized for marketing a growing number of devices through 510(k) clearance and granting of de novo requests with AR/VR across many different fields of medicine—and expects this trend to continue,” the administration said in a news release...
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