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Home » Augmedics wins FDA clearance for next-gen AR headset for use with Xvision Spine System

Augmedics wins FDA clearance for next-gen AR headset for use with Xvision Spine System

November 12, 2025 By Sean Whooley

Augmedics X2 Headset
The X2 headset for use with the Xvision Spine System. [Image courtesy of Augmedics]
Augmedics announced today that it received FDA 510(k) clearance for X2, its next-generation augmented reality (AR) headset.

X2 works with the company’s Xvision Spine System, which uses AR to give surgeons “X-ray vision” during surgery. The system superimposes critical data onto the surgical field, allowing surgeons to visualize patient anatomy through the skin and tissue. This FDA clearance adds to updates to the system cleared in the last couple of years, plus significant funding and the milestone of 10,000 procedures hit earlier this year.

Chicago-based Augmedics said that, unlike consumer-grade AR headsets intended for educational or entertainment use, it purpose-built X2 for surgery. It features an all-new form factor to maximize comfort, balance and wearability in the operating room. X2 also features a detachable, surgical-grade headlight and novel lens tilt to support surgeon ergonomics for standing and seated procedures.

Augmedics said it also developed X2 with enhanced technical and optical specifications to augment the surgical experience. Its transparent AR display features a 100% increase in field of view and image resolution with improved brightness relative to its predecessor.

The technology also has a high-performance processor and a more power-efficient design. It builds on Augmedics’ first-generation headset to deliver advanced AR visualization.

“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,” said President & CEO Paul Ziegler. “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.” 

Filed Under: 510(k), Artificial Intelligence (AI), Featured, Food & Drug Administration (FDA), Health Technology, Imaging, Machine Learning (ML), Orthopedics, Regulatory/Compliance, Software / IT, Spine, Surgical Tagged With: augmedics

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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