FDA Clears Zeta Surgical’s Navigation System & Instruments for Brain Surgery

Zeta Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zeta navigation system, as well as its Zeta Stylet and Zeta Bolt navigated instruments.

The system offers computer-assisted, real-time image guidance to position and orient neurosurgical instruments. Zeta leverages computer vision and artificial intelligence (AI) to align pre-op CT or MRI scans with anatomy for millimeter-level navigation at the point of care.

The newly cleared instruments allow navigated guidance for placement of catheters and shunts, brain biopsies, and trigeminal rhizotomies. The company said the functions target common neurosurgical interventions with limited neuronavigation support and provide critical care for patients with 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, COO 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.”

In a recent 15-patient first-in-human-trial assessing Zeta for ventriculostomies, the system achieved single-pass, ideal placements with a median setup time of less than three minutes. The company said it plans to begin a large 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, Zeta Surgical’s co-founder 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.”

In October, the company earned FDA clearance for its Zeta TMS (transcranial magnetic stimulation) navigation system. TMS is used in neuropsychiatry, especially for treatment-resistant major depressive disorder, which impacts about a third of patients with major depression globally.