FDA grants 510(k) approval for Xvision Spine system an augmented reality guidance system for surgery. Augmedics

Augmedics, a pioneer in augmented reality surgical image guidance, has announced FDA 510(k) clearance and the U.S. launch of its groundbreaking Xvision Spine system (XVS), the first AR guidance system to be used in surgery.

Xvision Spine allows surgeons to visualize the 3D spinal anatomy of a patient during surgery as if they had �x-ray vision,� and to accurately navigate instruments and implants while looking directly at the patient, rather than a remote screen. The system uses a transparent near-eye-display headset and the components of a traditional navigation system, allowing the user to simultaneously see navigation data as well as the patient without turning to look at a monitor. The augmented reality device accurately tracks the position of surgical tools and overlays a virtual trajectory on the patient�s computed tomography.

Comment: According to Technavio, the global market size for surgical navigation systems is estimated to grow to $900 million by 2020, with compounded annual growth rate (CAGR) of seven percent. Augmedics intends to disrupt this sizeable market with its ViZOR System, an AR surgical visualization system designed to give surgeons �X-ray vision� during complex procedures.