News and Publications

NEWS AND PUBLICATIONS

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Jul 2026

Zeta Surgical today announced that its Zeta TMS Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is classified as a Class II stereotaxic instrument under 21 CFR 882.4560 and product codes SGE and QFF (K261471).

Zeta TMS Robotic System Receives FDA 510(k) Clearance

Jun 2026

Zeta Surgical and HOPE Therapeutics, an NRx Pharmaceuticals company, today announced the first patient treatment with the FDA-cleared Zeta TMS Navigation System at a HOPE Therapeutics clinic in Sarasota.

First patient with Zeta TMS Navigation System at HOPE Therapeutics

May 2026

The system will be utilized at HOPE Therapeutics in West Palm Beach, Florida, to deliver high-precision navigated Transcranial Magnetic Stimulation (TMS) for the treatment of Major Depressive Disorder and other neurological conditions.

First Commercial Deployment of Zeta TMS Navigation System at HOPE Therapeutics

May 2026

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).

Zeta Surgical® Receives FDA 510(k) Clearance Expanding Access to Brain Tumor Biopsies, Hydrocephalus, and Trigeminal Neuralgia

Apr 2026

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.

NRx Pharmaceuticals Advances Robotic-Enabled Transcranial Magnetic Stimulation Combined with Neuroplastic Therapy for Military and First Responder Applications

Feb 2026

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

REALTRACK™ Foundational Patent Published

Oct 2025

Zeta TMS Navigation System 510(k) FDA approval

Zeta Surgical® AI-powered TMS Navigation System Receives FDA 510(k) Clearance

Nov 2024

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

SCOUT: Skull-Corrected Optimization for Ultrasound Transducers

STUDY COMPLETED

STUDY COMPLETED

Jun 2024

Zeta Surgical, a surgical robotics and mixed reality company, announced today the completion of its first multicenter clinical trial using the Zeta Cranial Navigation System.

Zeta Surgical's AI-Powered Navigation System Successfully Completes First Clinical Study

Nov 2023

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

High-Accuracy Neuro-Navigation with Computer Vision for Frameless Registration and Real-Time Tracking.

STUDY COMPLETED

STUDY COMPLETED

Jun 2022

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

Stereotactic Neurosurgical Robotics With Real-Time Patient Tracking: A Cadaveric Study

STUDY COMPLETED

STUDY COMPLETED

Oct 2021

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

Frameless neuronavigation with computer vision and real-time tracking for bedside external ventricular drain placement: a cadaveric study

STUDY COMPLETED

STUDY COMPLETED

Dec 2020

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

Computer Vision Registration as a Novel and Accurate Approach for Frameless Stereotactic Neuronavigation

STUDY COMPLETED

STUDY COMPLETED

Unlock the future of surgery

ZETA 1. is indicated for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites. The use of the ZETA Cranial Navigation System for ventriculostomy, brain biopsy and transcranial magnetic stimulation require separate compatible instruments and accessories. ©️ 2026 ZETA Surgical Inc. All rights reserved. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to ZETA Surgical, its subsidiaries or affiliates. No use of any ZETA Surgical trademark, trade name, or trade dress in this site may be made without the prior written authorization of ZETA Surgical, except to identify the product or services of the company.