First AR Surgical Navigation System Achieves FDA Approval for Spine Surgery

VisAR from Novarad can now be used for precision guided intraoperative spine surgery.

The augmented reality surgical navigation system VisAR from Novarad has received approval from the United States Food and Drug Administration (FDA) for precision guided intraoperative spine surgery.

VisAR transforms a patient’s imaging data into a 3D hologram visible through a headset and superimposed onto the patient with high accuracy. This allows the surgeon to focus directly on the objective without looking away at 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,” 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 features integrated 2D and 3D immersive navigation views with continuous hologram-to-patient registration. It utilizes image visible CT fiducial markers for automatic registration and makes the operating room setup time less than 2 minutes. 

Novarad partnered with Microsoft to utilize the AR headset technology, which allows for lowered cost and the ability to leverage expected hardware advancements. According to the companies, Microsoft's HoloLens 2 visor results in a small OR footprint.

VisAR is currently available in the U.S., with plans to use the system in other countries in the coming months. Head and Neck surgical approvals are currently in the consideration phase with the FDA.

The VisAR system is a huge step towards making precision surgical guidance more available and economically feasible. Thankfully, more and more companies try to implement their tech in healthcare: earlier, Meta presented MyoSuite – a new AI platform that can build realistic musculoskeletal simulations and perform complex movements.

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