FDA clears Augmedics’ AR headset for use with spine surgery system

The company will introduce the headset at the North American Spine Society Annual Meeting in the US on 14 November.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Augmedics’ new augmented reality (AR) headset, X2, designed for use with the xvision Spine System.

The X2 is purpose-built for operating rooms and is distinct from mainstream AR headsets designed for wider consumer applications.

Its key features include a detachable, surgical-grade headlight and a new lens tilt function to accommodate various surgeon positions, whether standing or seated.

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