Zeta Surgical recently announced that its Zeta navigation system—alongside its navigated instruments, Zeta Stylet and Zeta Bolt—has received 510(k) clearance from the US Food and Drug Administration (FDA). The device is classified as a Class II stereotaxic instrument, as noted in a press release from the company.
“The US 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.”
Zeta provides computer-assisted, real-time image guidance for the spatial positioning and orientation of neurosurgical instruments, using computer vision and artificial intelligence (AI) to align preoperative computed tomography (CT) or magnetic resonance imaging (MRI) scans with patient anatomy, providing “millimetre-level navigation at virtually any point of care”, Zeta Surgical claims.
The company goes on to state that the newly cleared instruments provide navigated guidance for procedures including the placement of catheters and shunts, brain biopsies, and trigeminal rhizotomies—targeting “common neurosurgical interventions with limited neuronavigation support” to provide critical care for patients affected by conditions like brain tumours, trigeminal neuralgia, hydrocephalus, and traumatic brain injuries.
A recent 15-patient, first-in-human study evaluating Zeta for ventriculostomies demonstrated optimal outcomes across all cases, achieving single-pass, ideal placements with a median setup time of less than three minutes. Building on these results, Zeta Surgical plans to launch a large-scale commercial pilot programme with the Big 10 Neurosurgical Consortium this year.
“Our mission has always been to democratise high-quality neurosurgical care for all patients, independent of treatment site,” commented Zeta Surgical co-founder William Gormley (Harvard Medical School, Boston, USA). “Today, the US FDA has taken a step forward in this mission with its approval of the latest set of Zeta’s instruments intended to perform complex neurosurgical procedures—not only in sophisticated operating rooms at tertiary care centres, but also at the patient’s bedside, and in any community hospital and ambulatory surgical centre in the world.”
