ZETA

Boston, MassachusettsFounded 201811–50 employeeszetasurgical.com

Neuromodulation
Neuroimaging

ZETA Surgical develops next-generation AI-powered neuronavigation technology for cranial and image-guided procedures. Its ZETA Cranial Navigation System uses standard CT and MRI scans, markerless registration, and real-time guidance to help surgeons improve precision, safety, and accessibility.

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FDA 510(k)FDA clearance (510(k)): 1
Founded: 2018
Employees: 11–50

reccy insights

Written by reccy's AI from company sites, press and funding records · updated Oct 2026

Recent highlights

ZETA Surgical moved from regulatory clearance toward commercial use during 2026. On May 1, 2026, the company received FDA 510(k) clearance expanding the Zeta Navigation System and related Zeta Stylet and Zeta Bolt instruments to brain tumor biopsies, hydrocephalus, and trigeminal neuralgia procedures. On May 26, 2026, ZETA announced a commercial collaboration with HOPE Therapeutics, whose West Palm Beach clinic began deploying the Zeta TMS Navigation System for navigated transcranial magnetic stimulation. The first patient treatment and installations at HOPE clinics in Sarasota and West Palm Beach were reported on Jun 23, 2026. A further milestone came in July, when the Zeta TMS Robotic System received FDA 510(k) clearance. By Sep 11, 2026, HOPE Therapeutics had begun training and deployment activities involving the system. These developments indicate that ZETA is expanding beyond neurosurgical navigation into guided brain-stimulation workflows, while relying on clinical installations and partner-led deployment to demonstrate use in practice. Public information does not identify material hiring activity or leadership changes during the period.

Market position

ZETA Surgical operates at the intersection of medical devices, neurosurgical navigation, robotics, augmented reality, and AI-enabled imaging. Its primary distinction is an attempt to make image-guided procedures faster to deploy and less dependent on rigid patient fixation: the company describes deployment in under five minutes, markerless registration, and compatibility with standard CT and MRI scans. RealTrack is designed to align camera capture with a patient-specific 3D model and provide continuous movement adjustment, while the clinical dashboard exposes trajectory guidance and accuracy metrics. The Zeta Navigation System and Zeta TMS Navigation System are both described as FDA-cleared and commercially available in the United States. Instead, ZETA’s clearest market position is as a specialized platform supplier spanning cranial navigation and robotic TMS, with its 2026 HOPE Therapeutics collaboration providing an early commercial reference point. Its five granted patents also suggest proprietary depth, although patent scope and commercial defensibility remain unclear.

Growth & opportunities

ZETA Surgical’s growth trajectory shows a progression from early technical development to regulated product commercialization. The company was founded in 2018 and raised $80,000 in a 2020 Seed round led by Artesian VC, followed by an $8.8455 million Seed round announced on Mar 10, 2022 with Innospark Ventures as lead investor. Its $5 million Series A on Jan 21, 2025 brought total reported funding to $13.9255 million. Product development initially centered on the Zeta Cranial Navigation System, RealTrack markerless registration, AI-based CT and MRI analysis, and real-time surgical guidance. Regulatory expansion accelerated in late 2024 and 2026: an expanded clearance was reported in November 2024, broader indications followed on May 1, 2026, and the Zeta TMS Robotic System received 510(k) clearance in July 2026. The 2026 HOPE Therapeutics collaboration, first patient treatment on Jun 23, 2026, and deployment training by September represent the latest inflection point, shifting the company toward repeatable clinical adoption.

Written by reccy's AI from company sites, press and funding records · updated Oct 2026

What makes ZETA distinct

reccy insights

What makes ZETA distinct

01Ultra-fast deployment in under five minutes without pins, clamps, anesthesia, or rigid patient fixation.
02AI-powered analysis of standard CT and MRI scans to construct high-resolution 3D head models.
03Markerless RealTrack technology continuously aligns real-time camera capture with the patient model and adjusts for movement.
04Real-time surgical guidance and accuracy metrics displayed through a clinical dashboard.
05Multidisciplinary expertise spanning neurosurgery, brain stimulation, engineering, science, design, and healthcare operations.

Technology & products6

Technology & products

RealTrack
An AI-powered navigation system offering sub-millimeter precision for surgical procedures and reducing reliance on traditional methods.
Zeta Cranial Navigation System
An FDA-cleared mixed-reality navigation system designed for neurosurgical procedures.
HD Touchscreen
A high-resolution interface for intuitive interaction with the navigation system.
High Performance Computer
A surgical-data processing system equipped with a 64-core CPU, two NVIDIA RTX A6000 GPUs, and 64GB of RAM.
Tracker
A passive instrument tracker designed for a wide range of surgical tools.
High Accuracy IR Camera
A camera providing real-time, sub-millimeter 3D imaging during surgeries.

Show all 6 products

+ 3 more: High Performance Computer, Tracker, High Accuracy IR Camera

FDA regulatory

From FDA filings where ZETA is the applicant

510(k)· Class IIClass II
Zeta TMS Navigation System
Electromechanical Arm For A Transcranial Magnetic Stimulation System · K261471 · product code QFF
Cleared Jul 9, 2026

Recent updates4

Launches, partnerships and team changes from press coverage

Jun 23, 2026Product launch
Zeta Surgical and HOPE Therapeutics began clinical use of the FDA-cleared Zeta TMS Navigation System, with first patient treatment and installations at HOPE clinics in Sarasota and West Palm Beach, marking a key commercial rollout for guided TMS procedures.
prnewswire.com
May 26, 2026Partnership
Zeta Surgical entered a commercial collaboration with HOPE Therapeutics, under which HOPE Therapeutics’ West Palm Beach clinic will deploy and use the Zeta TMS Navigation System for navigated TMS treatments.
prnewswire.com
May 1, 2026Product launch
ZETA SURGICAL is bringing its Zeta Navigation System and associated navigated instruments Zeta Stylet and Zeta Bolt to the U.S. market following FDA 510(k) clearance as Class II stereotaxic instruments for various neurosurgical procedures.
prnewswire.com
Nov 11, 2024Product launch
Zeta Surgical's brain surgery navigation system uses computer vision and AI to provide real-time visual overlays on standard screens, enhancing neurosurgical procedures.
fiercebiotech.com

Show all 4 updates

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About ZETA

Products: RealTrack, Zeta Cranial Navigation System, HD Touchscreen, High Performance Computer, Tracker, High Accuracy IR Camera
Leadership: Raahil Sha, Co-Founder & CTOJose Amich, Co-founder and CEO
Focus areas: Medical devices, neurosurgery, neuronavigation, AI/ML, digital health, surgical technology, image-guided surgery, brain stimulation
Headquarters: Boston, Massachusetts
Founded: 2018
Employees: 11–50
Patents granted: 5 (Crunchbase)
Trademarks: 1