Augmedics Announces FDA Clearance of Its Next-Generation AR Headset, X2™

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CHICAGO--(BUSINESS WIRE)--Nov 12, 2025--

Augmedics, a pioneer in augmented reality (AR) surgical navigation, today announced FDA 510(k) clearance of X2™, its next-generation AR headset for use with the xvision Spine System®.

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Augmedics’ proprietary X2 headset is purpose built for surgery and delivers advanced AR visualization. Credit: Augmedics

Unlike consumer-grade AR headsets intended for educational or entertainment use, the proprietary X2 headset is purpose built for surgery. The all-new form factor is designed to maximize comfort, balance, and wearability in the operating room. X2 features a detachable, surgical-grade headlight and novel lens tilt to support surgeon ergonomics for standing and seated procedures.

X2 is also outfitted with enhanced technical and optical specifications to augment the surgical experience. The transparent AR display features a 100% increase in field of view and image resolution with improved brightness relative to its predecessor. With a high-performance processor and more power-efficient design, X2 builds on Augmedics’ first-generation headset to deliver advanced augmented reality 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 Augmedics 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.”

Augmedics will debut X2 at the North American Spine Society (NASS) Annual Meeting beginning November 14 in Denver, CO.

X2 has not been authorized as required by the rules of the Federal Communications Commission (FCC). Delivery to the end user is conditional upon successful completion of the applicable equipment authorization process. FCC rules do not address the applicability of consumer protection, contractual, or other provisions under federal or state law.

About Augmedics

Augmedics pioneers cutting-edge augmented reality technologies in an effort to improve surgical outcomes. The company’s revolutionary xvision Spine System® allows surgeons to see patients’ anatomy as if they have “x-ray vision” and accurately navigate instruments and implants during spine procedures. The first-of-its-kind, FDA-cleared xvision has been used to treat over 12,000 patients and implant more than 65,000 pedicle screws across 25 US states. Augmedics has received numerous awards and honors. To learn more, visit augmedics.com.

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CONTACT: Alexa Bourdage

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KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS

INDUSTRY KEYWORD: FDA SURGERY MEDICAL DEVICES HEALTH HEALTH TECHNOLOGY

SOURCE: Augmedics

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PUB: 11/12/2025 09:15 AM/DISC: 11/12/2025 09:15 AM

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