# NaoTrac: robot model

Canonical ID: `f9d455c1-678b-4cf4-9a7d-37f593be85bc`

- **Slug:** brain-navi-naotrac
- **Form factor:** surgical
- **Maturity stage:** commercial
- **Lifecycle:** active
- **Deployments registered:** 0

## Specs

- **notes:** [object Object],[object Object],[object Object],[object Object]
- **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).
- **formFactor:** surgical (neurosurgical navigation robot: robotic arm + AI-driven non-contact frameless registration; positions instruments along planned trajectories)

## Deployments

_No deployments registered for this model._

## Supply chain

_No verified supply relationships on file. Supply-chain coverage is being added across the registry; check back as the seed populates this model's suppliers._

_Suppliers appear when verified with at least two strong sources. Sources are append-only; corrections add new sources rather than rewrite history._

## 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.

### Who makes NaoTrac?

NaoTrac is made by Brain Navi, based in Zhubei, Taiwan, founded in 2015.

### Where is NaoTrac deployed?

No verified deployments of NaoTrac are currently on the DEPLOY registry. DEPLOY records deployments only when verified at a named site with a primary source; absence may reflect pre-deployment, research, or manufacturer-internal use.

### What is NaoTrac's maturity stage?

NaoTrac is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.


## 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

_API: GET /v1/models/f9d455c1-678b-4cf4-9a7d-37f593be85bc · canonical URL: /models/brain-navi-naotrac_