Augmedics gets FDA clearance for AR-guided surgery system

By staff writers

December 23, 2019 -- The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to surgical technology company Augmedics for use of its xvision augmented reality (AR) guidance system in spinal surgery.

Xvision allows clinicians to examine real-time CT data alongside 3D spinal anatomy superimposed on the patient while performing a procedure. The advanced image-guided technology also enables clinicians to navigate the positioning of surgical instruments and implants during procedures without having to look at a remote screen away from the patient.

Recent studies at Rush University Medical Center in Chicago and the Johns Hopkins Hospital in Baltimore showed average accuracy as high as 98.9% for screw placement using xvision, as confirmed by neuroradiologists.

Xvision consists of a customizable AR headset with an integrated headlight that is compatible with all standard intraoperative 3D scanners, Augmedics said. The device is currently available for purchase in the U.S., with distribution slated to begin in early 2020.

Copyright © 2019

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