Novarad announces FDA 501(k) approval for its VisAR 3D Augmented Reality surgical navigation system for precision spine surgery

In Augmented Reality News 

June 17, 2022 – VisAR, an augmented reality (AR) surgical navigation system from healthcare technology provider Novarad, has received FDA 510(k) approval for precision guided intraoperative spine surgery.

According to Novarad, VisAR transforms a patient’s imaging data into a 3-dimensional hologram that can be viewed through an optical visor and superimposed onto a patient with submillimeter accuracy. This allows surgeons to focus directly on the surgical objective without looking away at a separate monitor. Most surgeries are performed without navigation due to the impediments of cost and setup time, however the VisAR system marks a big step towards making precision surgical guidance widely available and economically feasible, Novarad stated.

“This is transformational technology that provides the precision of a robot, the portability of a stethoscope and the versatility of human powered intelligence,” said Dr. Wendell Gibby, Novarad CEO and co-creator of VisAR. “Like a surgical GPS, VisAR provides a roadmap to guide the surgeon to the pathology of interest.”

VisAR is an end-to-end solution with pre-surgical planning, virtual annotations, segmentation and bi-directional image connectivity. It features integrated 2D and 3D immersive navigation views with continuous hologram-to-patient registration. VisAR technology utilizes image visible CT fiducial markers for automatic registration. The operating room setup time is less than 2 minutes. Surgical accuracy is sub 2 mm for pedicle screw placement in both open and minimally invasive surgical (MIS) procedures.

“My first impression of the technology, when you actually got to put it on and see real patient images come up was, ‘this is amazing. This is groundbreaking, revolutionary technology.’ It’s hard to explain,” said neurosurgeon from the University of Utah, Michael Karsy, MD PHD. “I’ve seen other technologies in the medical field, including virtual reality and other augmented reality systems. VisAR is ahead of the game and the people behind it have a real interest and passion to get this right.”

Novarad has partnered with Microsoft to utilize off-the-shelf AR headset technology which allows for lowered costs and the ability to leverage expected hardware advancements. The untethered wirelessly connected Microsoft HoloLens 2 visor worn by a physician results in the smallest OR footprint of any system on the market, according to the company. No other navigation equipment is required. VisAR is built on the Novarad imaging technology solution stack that provides interoperability, HIPAA compliance, image management, and deep security.

VisAR is currently available in the US, with usage being anticipated in other countries in the coming months. Head and Neck surgical approvals are currently in the consideration phase with the US Federal Drug Administration (FDA).

For more information on Novarad and its healthcare technology, including VisAR, please visit the company’s website.

Image / video credit: Novarad / YouTube


About the author

Sam Sprigg

Sam is the Founder and Managing Editor of Auganix. With a background in research and report writing, he has been covering XR industry news for the past seven years.