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FDA OKs Augmedics’ Next-Gen AR Headset with xvision Spine

The next-gen AR headset boasts a detachable, surgical-grade headlight and new lens.

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By: Sam Brusco

Associate Editor

The X2 headset is purpose-built for surgery and delivers advanced augmented reality (AR) visualization. Photo: Augmedics

Augmedics, a company that specializes in augmented reality (AR) surgical navigation, has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation X2 AR headset with the xvision Spine system.

The company said X2’s new form factor was engineered to maximize comfort, balance, and wearability in the operating room. The next-gen AR headset boasts a detachable, surgical-grade headlight and new lens tilt to support ergonomics for standing and seated surgeries.

A transparent AR display touts a 100% increase in field of view and image resolution compared to X2’s predecessor. X2 also features a high-performance processor and a more power-efficient design, Augmedics 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,” said Augmedics President and 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.”

The 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 company plans to debut X2 at this week’s North American Spine Society (NASS) meeting.

Earlier this year, Augmedics celebrated 10,000 patients successfully treated with the xvision Spine system.

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