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.
Precision that STRENGTHENS EVERY TREATMENT SESSION
PATIENT impact
ZETA delivers sub-millimeter targeting accuracy (0.45 mm mean translational error), compared with 2–5 mm reported in many existing TMS navigation systems.
By maintaining on-target coil positioning, navigation preserves cortical dose fidelity—avoiding reductions that can fall to less than half of the intended electric field with misalignment.
As accelerated protocols such as SNT demonstrate remission rates of 57% in randomized trials and up to 90% in open-label studies, precise and consistent targeting becomes essential to fully realize their therapeutic potential.
STAFFING IMPACT
Real-time AI-powered tracking automates patient registration and motion compensation, reducing operator-dependent variability.
The system is designed for technician-led operation, minimizing reliance on specialist time while maintaining anatomical precision.
With setup in approximately one minute, daily workflows become more predictable and treatment capacity increases across providers.
FINANCIAL IMPACT
Under ZETA’s AI-enabled workflow, a single TMS suite can support up to five full treatment courses per week—maximizing clinical capacity within a standard outpatient room.
A technician-led operating model reduces specialist time requirements while supporting scalable, economically efficient outpatient delivery.
With setup times of approximately one minute—compared to more than ten minutes in many existing systems—navigation increases daily treatment throughput per suite.
WORKFLOW
Deployment in minutes and single-cart portability enable seamless integration into outpatient clinics without dedicated navigation infrastructure.
RealTrack™ AI technology provides automatic, real-time patient registration and tracking, maintaining precision even during patient movement.
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
NEWS
PUBLICATION
NEWS
PUBLICATION
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
NEWS
PUBLICATION
NEWS
PUBLICATION
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
NEWS
PUBLICATION
NEWS
PUBLICATION
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
NEWS
PUBLICATION
NEWS
PUBLICATION