Zeta Surgical Receives FDA Approval for its Mixed Reality Navigation System

Zeta Surgical has received the U.S. Food and Drug Administration (FDA) clearance for the Zeta Cranial Navigation System, its mixed reality surgical navigation system for neurosurgery that provides surgeons with “GPS-like” guidance with millimetric accuracy in real time.

Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement. Zeta can be deployed both inside and outside the operating room, eliminating the need for general anesthesia and rigid skull immobilization.

Dr. William Gormley, Chief Medical Officer of Zeta Surgical and Harvard Medical School Associate Professor, commented on the clearance: “The FDA’s market clearance of the Zeta Navigation system ushers in the next generation of innovation to neurosurgery. Like all paradigm changing innovations, Zeta will change the way we conceive of where we can perform neurosurgery within our hospitals and where in the world these hospitals can be.”

“Zeta Surgical has created a platform technology that not only improves existing techniques and workflows but also enables novel therapies, expanding the scope of treatment for neurologic diseases,” said Dr. Kyle Wu, Director of Neurosurgical Innovation at The Ohio State University Wexner Medical Center.

“Not only can the Zeta platform be used to navigate the most complex cranial surgeries, but it can also enable more routine cranial surgeries to be done in lower cost settings outside of a traditional OR without the need for general anesthesia,” said Dr. Matthew McGirt, Professor of Neurosurgery at Atrium Health-Wake Forest, and a Director at the Carolina Neurosurgery & Spine Associates. “Few technologies improve both quality and cost for hospital systems like Zeta does.”


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