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

"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..." Lire la suite