Augmedics gets FDA clearance for spine system: 5 things to know

Spinal Tech

Augmedics received FDA clearance for the xvision Spine System, which it launched in the U.S. on Dec. 23.


Five things to know:

1. The xvision technology is an AR guidance system designed for spine surgery. It allows surgeons to visualize the 3D spinal anatomy intraoperatively, making it seem as though the surgeon has X-ray vision.

2. The surgeon can use the technology to navigate surgical instruments while looking at the patient instead of a remote screen.

3. Augmentics' xvision system includes a transparent near-eye-display headset and other elements of a traditional navigation system. It determines the surgical tool position and superimposes the virtual trajectory onto the patient's CT data, and then the 3D navigation data is projected onto the surgeon's retina using the headset.

4. Surgeons at Rush University Medical Center in Chicago have completed a percutaneous laboratory study using the xvision Spine, positioning 93 screws in the thoracic and sacro-lumbar areas of five cadavers. The clinical accuracy was 98.9 percent.

5. The technology is now available in the U.S. for sale, and distribution is expected to begin in early 2020. The company aims to explore additional applications beyond spine surgery in the future.

"The ability that Augmedics' xvision provides to visualize the patient's spinal anatomy in 3D, coupled with live CT images as a retina display, is game changing," said Frank Phillips, MD, professor of orthopedic surgery at Rush. "The efficiency and accuracy this augmented reality technology enables in placing spinal implants without looking away from the surgical field, as well as the ability to 'see the spine' through the skin in minimally invasive procedures, differentiates the xvision from conventional spinal navigation platforms. The economics of the xvision system are also compelling in both the hospital and the surgicenter environment."

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