Zeta Surgical announced today that the FDA cleared its mixed reality surgical navigation system for neurosurgery.
The Zeta cranial navigation system provides surgeons with GPS-like guidance and millimetric accuracy in real time. Boston-based Zeta Surgical designed it with a computer vision engine to ensure maintained accuracy. It automatically registers multiple times per second, accounting for patient movement.
According to a news release, users can deploy Zeta both inside and outside the operating room. This feature eliminates the need for general anesthesia and rigid skull immobilization.
In March 2022, Zeta Surgical announced that it raised $5.2 million to support its navigation and surgical robotic platforms. It listed one of its next steps following the funding as obtaining this FDA clearance.
“The FDA’s market clearance of the Zeta Navigation system ushers in the next generation of innovation to neurosurgery,” Dr. William Gormley, Zeta Surgical chief medical officer, said in a news release. “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.”