DEPLOYDatabase

Robot model

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…

Manufacturer
Brain Navi
Form factor
surgical
Maturity
commercial
Lifecycle
active
Deployments
2

Overview

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.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Verified deployments
2 deployments on file
Sources on file
3 sources, view all

Key facts

Form factor

surgical (neurosurgical navigation robot with robotic arm)

Autonomy level

AI-driven non-contact frameless registration is autonomous; autonomy is in navigation/registration step, not autonomous cutting or tissue manipulation

Regulatory approval

TFDA approval July 2022, CE mark, US FDA 510(k) clearance June 2025 (cleared as stereotaxic guiding device)

Maturity

commercial / early-commercial; multi-jurisdiction cleared but small startup with limited and unverified installed base

Specs

Notes

Verified: Brain Navi Biotechnology (founded 2015, Zhubei Taiwan; founder/surgeon Jerry Chen) makes NaoTrac, a genuine neurosurgical ROBOT (robotic arm/manipulator + autonomous registration). Gating events: TFDA approval Jul 2022, CE mark, and US FDA 510(k) clearance Jun 2025 (cleared as a stereotaxic guiding device)., Autonomy spectrum (notable): NaoTrac has the HIGHEST autonomy of the niche surgical set: AI-driven non-contact frameless REGISTRATION is autonomous. But the autonomy is in the navigation/registration step, NOT autonomous cutting/tissue manipulation - tag accordingly. The 'first autonomous neurosurgical navigation robot' superlative is a TFDA/marketing claim., Maturity = commercial / early-commercial: Multi-jurisdiction cleared (TFDA 2022, CE, FDA 510(k) Jun 2025), but a small startup with a limited installed base. Installed-base count NOT verified; lean early-commercial. Robot-substance is clear -> INCLUDE., Cap-flag: Exact installed-base count not verified; the 'first autonomous neurosurgical navigation robot' superlative is marketing. (Note: Brainlab's Cirq robotic arm is a separate, legitimate surgical-robot candidate deferred to a follow-on wave; Brainlab is navigation-software-first so the entity would be scoped to Cirq, not its broader software portfolio.)

Products

NaoTrac: neurosurgical navigation robot with a robotic arm + AI-driven non-contact frameless (autonomous) registration; positions instruments along planned trajectories for biopsy, tumor ablation, EVD, SEEG, DBS, endoscopy. TFDA approval Jul 2022; CE mark; US FDA 510(k) clearance Jun 2025 (stereotaxic guiding device).

Form Factor

surgical (neurosurgical navigation robot: robotic arm + AI-driven non-contact frameless registration; positions instruments along planned trajectories)

Fda clearance

US FDA 510(k) clearance in June 2025

Clearance body

Taiwan FDA, European CE mark, US FDA

Procedure types

biopsy, tumor ablation, external ventricular drainage, stereo-electroencephalography, deep-brain stimulation, and endoscopy

Data & sources

Press releases

2

Web sources

1

3 sources backing this record.View all →

Pricing

No verified price is on record for NaoTrac. Physical-AI systems are often sold through enterprise contracts or operated as a service rather than at a public list price.

Deployments (2)

  • NaoTrac at Spainoperational

    Following a demonstration at the SENEC (Spanish Society of Neurosurgery) Congress, a NaoTrac system was installed at a Spanish hospital in August 2025 and the country's first NaoTrac neurosurgery procedures were…

  • Erasmus MC in Rotterdam became the first site in the Netherlands to use the Brain Navi NaoTrac neurosurgical navigation robot, in July 2024.

NaoTrac on the deployment map

Where NaoTrac is verified operating. Explore the deployment map by place and type.

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Deployment-verified media (1)

PRIMARY SOURCE
Courtesy of Brain Navi

Brain Navi footage of its NaoTrac surgical-navigation robot for neurosurgery (presented at AANS 2025). Brain Navi markets NaoTrac as an 'Autopilot' and autonomous-navigation robot; this is the maker's claim.

From deployment: Spain

Regulatory filings (1)

Safety record

No incidents on record for NaoTrac.

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

Sources (3)

  1. https://www.prnewswire.com/news-releases/brain-navi-naotrac-us-fda-clearance
  2. https://www.prnewswire.com/news-releases/tfda-approves-naotrac-autonomous-neurosurgical-robot
  3. https://www.biospectrumasia.com/news/brain-navi-naotrac

Common questions

What is 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.
How much does NaoTrac cost?
NaoTrac's price is not publicly disclosed. DEPLOY has no verified price on record for NaoTrac from Brain Navi. Physical-AI systems like this are often sold through enterprise contracts or operated as a service rather than at a public list price; check the manufacturer for the latest.
Is NaoTrac actually deployed in the real world?
Yes. NaoTrac is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.
Is NaoTrac autonomous or teleoperated?
Not verified as fully autonomous. NaoTrac's capabilities on the DEPLOY registry are recorded as teleoperated-assisted, demonstrated-only, or vendor claims (Assists surgery), not independently confirmed to run without a human in the loop.
Who makes NaoTrac?
NaoTrac is made by Brain Navi, based in Zhubei, Taiwan, founded in 2015.
Methodology: Verified · 3 sources (2 primary) · last reviewed 2026-07-12

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-07-12

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

2
primary-company-ir
Company IR disclosure
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for NaoTrac.

Recent coverage

NaoTrac in third-party press