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.
Related: FDA clears ViTAA Medical’s AI aortic surgery planning tool
The AR display now delivers increased field of view and image resolution compared with the earlier version, with a notable enhancement in brightness.
Technological improvements in the X2 include a high-performance processor and a focus on energy efficiency, further advancing Augmedics’ initial generation of the headset.
The company will introduce the new device at the North American Spine Society (NASS) Annual Meeting in Denver, US, on 14 November.
According to Augmedics, delivery to customers will only proceed once the necessary equipment authorisation process through the US Federal Communications Commission (FCC) is complete.
FCC regulations do not cover provisions related to consumer protection, contracts, or other federal or state legal requirements.
Augmedics CEO and president Paul Ziegler said: “Augmedics was a pioneer in the field with the first AR guidance system to be used in surgery. We have continued to be a leader in the space with more than 12,000 patients treated with our first-generation technology.
“With that foundation established, we’re entering a new era in Augmedics history. X2 is a significant step forward and represents a proprietary platform for long-term procedural innovation.”
Augmedics’ xvision Spine System enables surgeons to visualise internal anatomy, supporting navigation of instruments and implants during spinal operations.
Since its launch, the system is claimed to have been used for more than 65,000 pedicle screw placements across 25 US states. Last year, the company gained FDA clearance for a CT-to-fluoroscopy registration method for its xvision Spine System.
