DEPLOYDatabase

Company

Brain Navi

Zhubei, Taiwan-based neurosurgical robotics company founded in 2015 by surgeon and serial entrepreneur Dr.

Track Brain Navi
Founded
2015
HQ
Zhubei, Taiwan
Status
private

Models

1

Overview

Zhubei, Taiwan-based neurosurgical robotics company founded in 2015 by surgeon and serial entrepreneur Dr. Jerry Chen. Brain Navi Biotechnology developed the NaoTrac, a neurosurgical navigation robot that received U.S. FDA clearance, Taiwan FDA approval, and CE Mark. The NaoTrac provides high-precision robotic surgical navigation for cranial procedures.

Verified record

Verified deployments
None on file
Active incidents
None on file

DEPLOY Intelligence

Market intelligence for physical AI

Analyst-grade signals, competitive tracking, and investment context across the global physical AI landscape. Launching 2026.

Key facts

Product

NaoTrac neurosurgical navigation robot

Gating events

TFDA Jul 2022; CE mark; US FDA 510(k) Jun 2025.

CEO

Dr. Jerry Chen (Chieh Hsiao Chen)

Approvals

FDA, Taiwan FDA, CE Mark

Data & sources

Press releases

2

Web sources

1

3 sources backing this record.View all →

Models (1)

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Current platform

NaoTrac

Brain Navi Biotechnology (founded 2015 in Zhubei, Taiwan by the surgeon Jerry Chen) makes NaoTrac, a neurosurgical navigation robot that combines a robotic arm with AI-driven non-contact frameless registration to position instruments along pre-planned trajectories for procedures such as biopsy, tumor ablation, external ventricular drainage, stereo-electroencephalography, deep-brain stimulation, and endoscopy. It is a genuine surgical robot with a real robotic manipulator, and it has cleared its gating events across multiple jurisdictions, with Taiwan FDA approval in July 2022, a European CE mark, and US FDA 510(k) clearance in June 2025 as a stereotaxic guiding device. NaoTrac has the highest autonomy of the niche surgical set in this wave, since its AI-driven non-contact frameless registration is autonomous, but that autonomy lies in the navigation and registration step rather than in autonomous cutting or tissue manipulation, and the first-autonomous-neurosurgical-navigation-robot framing is a regulatory and marketing superlative. The registry records it at commercial, leaning early-commercial, maturity: it is cleared across Taiwan, Europe, and the US but remains a small startup with a limited and unverified installed base. For category context, Brainlab's Cirq robotic arm is a separate and legitimate surgical-robot candidate deferred to a follow-on wave, where the entity would be scoped to the Cirq arm rather than Brainlab's broader navigation-software portfolio.

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Brain Navi on the deployment map

Where Brain Navi's robots are verified operating. Explore the deployment map by place and type.

Explainers

Plain-language answers to the questions people ask about Brain Navi, from DEPLOY’s explainer library. Each is written in the language of the question and cross-checked against this registry.

  • What is a surgical robot?

    A surgical robot is a computer-assisted operative platform that places robotic arms, instruments, and visualization systems between the surgeon and the patient. The 2026 commercial cohort includes Intuitive Surgical (da Vinci + Ion; 11,395 + 1,041 systems installed per SEC 10-Q), Medtronic Hugo, CMR Surgical Versius, Asensus/Karl Storz Senhance, Stereotaxis Genesis, Distalmotion Dexter, Moon Surgical Maestro (ScoPilot is the cohort's genuine shipped surgical AI standout, FDA-cleared with a Predetermined Change Control Plan), and Brain Navi NaoTrac (autonomous registration, not tissue manipulation). J&J Ottava (De Novo submission January 2026) and Vicarious Surgical V1 remain pre-market research per DEPLOY's FDA-clearance-as-gating-event framework. The autonomy spectrum runs from teleoperated baseline through analytics AI to narrow autonomous registration; tissue-manipulation autonomy remains research demos on production hardware, not shipped product.

Current leadership (1)

Founders (1)

Safety record

No incidents on record for Brain Navi.

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Full safety record: incidents, sourcing, and exposure data →

Recent coverage

Brain Navi in third-party press

Brain Navi achieves U.S. FDA approval for neurosurgical robot NaoTrac

Jul 1, 2025

Brain Navi achieves U.S. FDA approval for neurosurgical robot NaoTrac

Jan 1, 2025

Brain Navi wins FDA nod for neurosurgical robot

Jan 1, 2025

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