FDA clears augmented reality system to help navigate spine surgery

[The U.S. Federal Drug Administration has approved a new system for spinal surgery that “convert[s] imaging data into either a 2D or 3D immersive hologram” and superimposes the “navigation plan right on the patient’s body” during the operation. The details, and links to two other applications of presence-evoking technology in the operating room, are presented in this story from Fierce Biotech. See the Novarad press release for more information including a one-minute video (also on Vimeo). Another Fierce Biotech story reports on FDA approval of a Lensar system that incorporates augmented-reality imaging technology for cataract surgery. –Matthew]

FDA clears augmented reality system to help navigate spine surgery

By Andrea Park
June 16, 2022

Just as a driver uses a road map or GPS to navigate unfamiliar streets, so too can surgeons access surgical navigation systems to guide them through the unique plains of a patient’s anatomy.

The standard systems, however, can be unwieldy both in setup—since they may require the navigation plan to be manually mapped out and typically force physicians to repeatedly shift their gaze back and forth between the patient and an onscreen guide—and in cost, with high prices for the technology often barring surgical teams from using it at all.

A high-tech option from Novarad attempts to knock down all of those barriers. Not only does it use augmented reality technology to superimpose the navigation plan right over the patient’s body, but it also relies solely on off-the-shelf AR hardware to significantly lower costs.

The VisAR technology has now been cleared by the FDA to provide guidance during spinal surgeries, Novarad announced this week, giving U.S. surgeons a new, potentially more efficient alternative to their existing surgical navigation systems.

Physicians first analyze a patient’s imaging data with the VisAR platform’s pre-surgical planning software, which allows them to add virtual annotations to and perform segmentation on collected scans.

From there, they can opt to convert the imaging data into either a 2D or 3D immersive hologram, which is then mapped directly onto the patient’s body, using markers from the CT scan to position the hologram accurately. According to Novarad, using the virtual map as a continuous guide can help surgeons place pedicle screws along the spine with accuracy of within two millimeters.

Physicians view the hologram throughout the procedure using Microsoft’s HoloLens 2 augmented and virtual reality headset, thanks to a partnership between Novarad and the tech giant. The headset’s retail price starts at $3,500.

No other hardware is required, and Novarad said the total setup time for the navigation system in the operating room tops out at around two minutes.

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

Next up, Novarad is aiming to secure international approvals for the spine guidance system, plus additional U.S. clearances for head- and neck-focused versions of the technology—which are currently in the FDA’s “consideration phase,” the Salt Lake City-based company said.

Augmented and virtual reality technologies have become increasingly popular in the OR. Medtronic, for one, struck a partnership with Surgical Theater last year to bring fighter-jet simulator software to brain surgery, placing a 3D rendering of a patient’s brain over the actual organ to help guide instruments through that treacherous territory.

Also last year, the FDA cleared another AR-based technology for surgical navigation. That device, from Pixee Medical, comprises a pair of “smartglasses” that surgeons wear throughout a knee replacement surgery and use to scan virtual QR codes to track the alignment of surgical tools and the knee joint itself.

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