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Zeta Surgical’s Mixed Reality Navigation System Receives FDA Clearance

September 11, 2023


Zeta Surgical, a surgical robotics and mixed reality company, announced today that the U.S. Food and Drug Administration has cleared the Zeta Cranial Navigation System, its mixed reality surgical navigation system.

The Zeta Cranial Navigation System is a mixed-reality 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.”

About Zeta Surgical

Zeta Surgical is a digital surgery company focused on improving the accuracy, safety, and accessibility of image guided procedures. Its navigation and robotics platform leverages cutting-edge computer vision and artificial intelligence to enable surgical guidance directly at the point-of-care, democratizing care by creating new possibilities in fields such as emergency care, interventional medicine, and drug delivery. Zeta Surgical was founded by Harvard graduates and faculty and is backed by leading investors. To learn more, visit:

See Full Press Release at the Source: Zeta Surgical’s Mixed Reality Navigation System Receives FDA Clearance

Press Release by: Zeta Surgical

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