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 prototype is being developed in partnership with Zeta Surgical, Inc., whose AI-powered neuronavigation platform received FDA 510(k) clearance for TMS navigation in October 2025.

The core of Zeta’s marker-less, real-time image guidance—built for fast setup and sub-millimetric accuracy in real clinical workflows.

Zeta TMS Navigation System 510(k) FDA approval

Zeta Surgical, Harvard Medical School, Brigham and Women's Hospital, Imperial College London

Zeta Surgical, Harvard Medical School, Masschusetts General Hospital, Brigham and Women's Hospital

Zeta Surgical, Harvard Medical School, Brigham and Women's Hospital, SingHealth Duke-NUS, National Neuroscience Institute

Zeta Surgical, Harvard Medical School, Massachusetts General Hospital, Brigham and Women's Hospital, Harvard John A. Paulson School of Engineering and Applied Sciences, SingHealth Duke-NUS, National Neuroscience Institute

Zeta Surgical, Harvard Medical School, Brigham and Women's Hospital, Massachusetts General Hospital