ZETA SURGICAL announced that its Zeta Navigation System, alongside its navigated instruments, Zeta Stylet and Zeta Bolt, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is classified as a Class II stereotaxic instrument (21 CFR 882.4560) under product code HAW (K253663).

Zeta provides computer-assisted, real-time image guidance for the spatial positioning and orientation of neurosurgical instruments. The system uses computer vision and artificial intelligence to align preoperative CT or MRI scans with patient anatomy, providing millimeter-level navigation at virtually any point-of-care. The cleared instruments provide navigated guidance for procedures such as the placement of catheters and shunts, brain biopsies and trigeminal rhizotomies. These capabilities target common neurosurgical interventions with limited neuronavigation support, providing critical care for the millions of patients affected globally by conditions 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," said Hieu Le Mau, Chief Operating Officer at ZETA SURGICAL. "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 Zeta for ventriculostomies demonstrated optimal outcomes across all cases, achieving single-pass, ideal placements with a median setup time under three minutes. Building on these results, ZETA SURGICAL plans to launch a large-scale commercial pilot program with the Big 10 Neurosurgical Consortium this year.

"Our mission has always been to democratize high quality neurosurgical care for all patients, independent of treatment site," said Dr. William Gormley, Co-Founder of ZETA SURGICAL and Director of Neurosurgical Innovation at Harvard Medical School's Brigham and Women's Hospital. "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."