Israel’s Augmedics Gets FDA Nod For AR Surgical Spine Guidance System

Israeli firm Augmedics, a developer of augmented reality surgical systems, announced that it received 510(k) clearance from the US Food and Drug Administration for its xvision spine system, an AR headset for surgical procedure.

The xvision system will be available for sale in the US, with headset distribution expected to begin in early 2020.

Founded in 2014 by Nessi Benishti and Nissan Elimelech, Augmedics developed a headset with goggles that projects an “x-ray vision”-like 3D visualization of the spinal anatomy of a patient in real-time for surgeons. This allows the surgeon to accurately navigate instruments and implants while looking directly at the patient, rather than at a remote screen.

“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, M.D., professor of Orthopaedic Surgery at Rush University Medical Center, where researchers used xvision to successfully complete a laboratory study. The study, which had 98.9 percent accuracy, was conducted as evidence to the FDA to evaluate the system.

“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,” Dr. Phillips added.

“Augmedics’ mission is to give surgeons more control by creating technological advances that cater to their needs and fit within their workflow,” said Elimelech, CEO of Augmedics. “Xvision is our first product of many to follow that will revolutionize surgery, as it gives surgeons the information they need, directly within their working field of sight, to instill technological confidence in the surgical workflow and help them do their jobs as effectively and safely as possible.”