FDA Clears Zeta Navigation System for Image-Guided Neurosurgery

The Food and Drug Administration (FDA) has granted 510(k) clearance to the Zeta Surgical Navigation System, along its accompanying instruments, Zeta Stylet and Zeta Bolt (Zeta Surgical, Boston, MA) for use in stereotactic neurosurgical procedures. The system is classified as a Class II stereotaxic instrument and is designed to provide real-time, computer-assisted image guidance for the positioning and orientation of neurosurgical tools.

The Zeta Surgical Navigation system integrates preoperative CT or MRI imaging with patient anatomy using computer vision and artificial intelligence, enabling spatial navigation with millimeter-level precision. According to a statement from the company, the cleared instruments are intended to support a range of procedures, including catheter and shunt placement, brain biopsy, and trigeminal rhizotomy.

In a first-in-human study of 15 patients undergoing ventriculostomy, use of the Zeta Surgical Navigation system was associated with successful single-pass catheter placement in all cases and a median setup time of less than 3 minutes.

These findings suggest the device may facilitate efficient and accurate neurosurgical interventions at the point of care, although larger studies are needed to further evaluate clinical outcomes and broader applicability.

Source

Zeta Surgical. Zeta Surgical receives FDA 510(k) clearance expanding access to brain tumor biopsies, hydrocephalus, and trigeminal neuralgia. PR Newswire. Published May 1, 2026. Accessed May 4, 2026. https://www.prnewswire.com/news-releases/zeta-surgical-receives-fda-510k-clearance-expanding-access-to-brain-tumor-biopsies-hydrocephalus-and-trigeminal-neuralgia-302760338.html