FDA Clears Augmedics’ X2 AR Headset for Surgical Navigation

• Augmedics has secured FDA clearance for X2, a redesigned AR headset developed for use with its xvision Spine System.
• The device introduces a new ergonomic build, upgraded optics, and an expanded field of view aimed at enhancing surgical performance.

Augmedics has received regulatory approval for X2, the latest version of its augmented reality headset tailored for spine surgery. The system is engineered specifically for operating room use, distancing itself from consumer AR headsets.

X2 is designed for use with the xvision Spine System, Augmedics’ platform for augmented reality surgical navigation. The headset introduces a new form factor with balanced weight distribution and improved wearability for long procedures. It includes a detachable surgical-grade headlight and an adjustable lens tilt for seated or standing operations. Technical upgrades include a transparent AR display with twice the field of view and resolution of the previous model, along with improved brightness and a more efficient processor.

X2 will debut at the North American Spine Society Annual Meeting. While cleared by the FDA, delivery is pending completion of the FCC equipment authorization process. Augmedics’ first-gen system has already been used in over 12,000 patient procedures.

🌀 Tom’s Take:

X2 shows how lessons from the field are driving real upgrades in comfort, visibility, and performance for surgical teams.

Source: Business Wire / Augmedics