The system uses artificial intelligence to provide real-time guidance for brain biopsies, shunt placements, and other neurosurgical procedures.
Zeta Surgical announced that its Zeta Navigation System, along with the Zeta Stylet and Zeta Bolt instruments, has received US Food and Drug Administration (FDA) 510(k) clearance. The system is designed to provide computer-assisted, real-time image guidance for the spatial positioning and orientation of neurosurgical instruments.
The device is classified as a Class II stereotaxic instrument. According to a press release from Zeta Surgical, the system uses computer vision and artificial intelligence to align preoperative CT or MRI scans with patient anatomy, providing millimeter-level navigation at various points of care.
The cleared instruments provide navigated guidance for procedures including the placement of catheters and shunts, brain biopsies, and trigeminal rhizotomies. These capabilities target neurosurgical interventions that often have limited navigation support, such as traumatic brain injuries, brain tumors, and trigeminal neuralgia.
“The FDA clearance of the Zeta Stylet and Zeta Bolt marks a significant milestone for our surgical portfolio,” says Hieu Le Mau, COO at Zeta Surgical, in a release. “These instruments integrate directly with Zeta, giving surgeons greater precision and confidence across a range of neurosurgical procedures, from external ventricular drain placement and brain biopsy to shunt procedures and rhizotomy.”
A recent 15-patient first-in-human trial evaluating the system for ventriculostomies achieved ideal placements with a median setup time under three minutes, according to the company. Based on these results, Zeta Surgical plans to launch a commercial pilot program with the Big 10 Neurosurgical Consortium this year.
“Today the FDA has taken a step forward in this mission with their approval of the latest set of Zeta’s instruments intended to perform complex neurosurgical procedures, not only in sophisticated operating rooms at tertiary care centers, but also at the patient’s bedside, and in any community hospital and ambulatory surgical center in the world,” says Dr William Gormley, co-founder of Zeta Surgical and director of neurosurgical innovation at Harvard Medical School’s Brigham and Women’s Hospital, in a release.
Zeta Surgical is an image-guided surgery company that uses artificial intelligence to enable image guidance across various points of care. The Zeta Navigation System is currently commercially available in the US.
Photo caption: Zeta Surgical Navigation System
Photo credit: Zeta Surgical
