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