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 changes outcomes
PATIENT impact
<5-minute system deployment with no skull fixation required, enabling deployment in virtually any operative setting, including emergency rooms and ambulatory centers.
100% single-pass accuracy of EVD catheter placement in a multi-center study – eliminating the need for catheter revisions and reducing the risk of ventriculostomy-related infection.
Reduces the risk of post-operative pulmonary complications and injuries associated with skull fixation in cranial procedures.
STAFFING IMPACT
No anesthesiologist or surgical tech required, thanks to a simplified workflow.
Patients can bypass Phase I PACU for procedures such as brain biopsy, reducing nursing hours and post-op care resources.
Reduces reliance on neuro-OR scrub nurses and radiology techs by taking cranial surgeries outside of the OR, easing staffing bottlenecks.
FINANCIAL IMPACT
Saves $2,150–$2,628 per EVD by avoiding costly catheter replacements and infection treatment.
Reduces $1,800 in variable OR costs per brain biopsy by minimizing procedure time.
Moving procedures such as brain biopsy cases away from neuro OR enables additional OR surgeries with up to $9,000 contribution margin per case — totaling $1.4M/year in added value for 200 annual cases.
WORKFLOW
Reduces procedure time from 5 hours to <3 hours for brain biopsies, improving case throughput.
Enables procedures outside the OR, freeing up premium surgical time for complex cases.
Submillimeter precision maintained in cranial procedures in real time even with rapid 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
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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
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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
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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
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