FDA-Cleared AR Surgery: Augmedics xvision and Medacta NextAR

Augmedics is a Chicago-based company that works on augmented reality image guidance for surgery. Its xvision Spine System pairs a transparent headset worn by the surgeon with the parts of a traditional navigation system. The system tracks surgical tools in real time and overlays a virtual trajectory on the patient's CT data, so the surgeon sees the navigation data while looking at the patient and not at a screen across the room. Augmedics announced FDA 510(k) clearance and the U.S. launch of xvision on December 23, 2019, and called it the first AR guidance system used in surgery.

Johns Hopkins surgeons completed their first operation with xvision on June 8, 2020, at The Johns Hopkins Hospital in Baltimore. Dr. Timothy Witham, Dr. Daniel Sciubba and Dr. Camilo Molina placed six screws during a spinal fusion that joined three vertebrae. The procedure combined a posterior lumbar decompression, the correction of a slipped vertebra and the fusion.

Medacta, an orthopedic device company, announced in late July 2020 that it had received FDA clearance for NextAR, an augmented reality surgical platform for total knee replacement. It was presented as the first application of a platform meant to extend later to hip, shoulder and spine procedures.

The Augmedics site presents the company as an augmented reality spine surgery company. It lists the xvision Spine System as its main product line and X2 as the current xvision offering. The site states that xvision is FDA approved for open or percutaneous spine procedures from C3 to pelvis, and it cites a 2020 paper in the Journal of Neurosurgery: Spine by Molina and colleagues for its accuracy statements. Readers who need regulatory detail should check the FDA's own database, because the wording on a manufacturer's page is the manufacturer's.

The NextAR site of Medacta describes one platform with three parts: personalized 3D planning from CT data, augmented reality shown on NextAR Smart Glasses, and a single-use infrared tracking system. It names hip, knee, shoulder and spine, with a NextAR Spine application that received the 2022 Spine Technology Award from Orthopedics This Week. The page makes no FDA claim and notes that products are not available in all countries because registration rules differ. The U.S. site of Medacta lists NextAR in its hip, knee and shoulder menus.

The case numbers in the 2020 press material, such as error rates for freehand screw placement, are left out here because they come from the makers' announcements and could not be traced to a primary study.