First Fully Immersive 3D Augmented Reality Surgical Navigation System Achieves FDA Approval for Precision Spine Surgery

VisAR, an augmented reality surgical navigation system from Novarad, receives FDA approval for interoperative stereotactic spinal surgical guidance.

SALT LAKE CITYJune 15, 2022 /PRNewswire/ — VisAR, an augmented reality surgical navigation system from healthcare technology leader Novarad™, receives FDA 510(k) approval for precision guided intraoperative spine surgery. VisAR transforms a patient’s imaging data into a 3-dimensional hologram which is visible through an optical visor and superimposed onto the patient with submillimeter accuracy. This allows the surgeon 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. The VisAR system is a big step towards making precision surgical guidance widely available and economically feasible.

“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 cost and the ability to leverage expected hardware advancements. The untethered wirelessly connected Microsoft HoloLens 2 visor worn by the physician results in the smallest OR footprint of any system on the market. 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 U.S., with usage being anticipated in other countries in the coming months. Head and Neck surgical approvals are currently in the consideration phase with the U.S. Federal Drug Administration. Visit novarad.net/visar for information or to schedule a demonstration.

About Novarad:

For over 30 years, Novarad has delivered innovative industry-leading medical technologies that truly transform healthcare for providers and their patients. The Enterprise imaging and departmental solutions from Novarad enable over 1,000 hospitals, imaging centers, and clinics to achieve even greater clinical, operational, and fiscal excellence. Visit Novarad at novarad.net.

SOURCE Novarad Corporation

About Peter Coffaro 448 Articles
A growth-driven and strategic executive, Peter Coffaro commands more than 20 years of progressive management success within the orthopedic industry. Recognized by MedReps.com and the World Journal of Orthopedics as one of the top medical sales influencers in the industry; he has 10 years of combined sales management experience and has held positions as a Director, General Manager, Distributor and Vice President. Peter has worked for some of the top orthopedic companies in the world - Zimmer, DePuy and Stryker. He is also the founder of OrthoFeed: a popular blog that covers digital orthopedic news and emerging medical technologies. Peter is a three-time Hall of Fame award winner at Johnson and Johnson and has an extensive background in organizational development, business development, sales management, digital marketing and professional education. Peter holds a B.S. degree in Biology from Northern Illinois University.

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