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Company

Brain Navi

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

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Founded
2015
HQ
Zhubei, Taiwan
Status
private
Models
1

Verified profile

  • 3

    Sources on record

  • 1

    Tracked changes

  • Updated 1 month ago

    Last verified change

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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

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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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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.

Recent coverage

Brain Navi in third-party press

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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