FDA OKs Fully Immersive VisAR Surgical Navigation for Spine Surgery

Novarad’s augmented reality (AR) surgical navigation system VisAR has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for precision guided intraoperative spine surgery.
 
VisAR turns patient imaging data into a 3D hologram visible through an optical visor and superimposed onto the patient with submillimeter accuracy, so the surgeon can focus directly on the objective without looking to a separate monitor.
 
“This is transformational technology that provides the precision of a robot, the portability of a stethoscope and the versatility of human powered intelligence,” Dr. Wendell Gibby, Novarad CEO and co-creator of VisAR told the press. “Like a surgical GPS, VisAR provides a roadmap to guide the surgeon to the pathology of interest.”
 
The end-to-end solution touts pre-surgical planning, virtual annotations, segmentation, and bi-directional image connectivity. Integrated 2D and 3D immersive navigation views provide continuous hologram-to-patient registration.
 
Operating room setup time is under two minutes according to the company, with surgical accuracy of sub 2 mm for pedicle screw placement in open and minimally invasive 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, Ph.D. “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 teamed up with Mocrosoft to use off-the-shelf AR headset tech, lowering cost and leveraging expected hardware advancements. No other navigation equipment is needed other than the untethered, wirelessly connected Microsoft HoloLens 2 visor.