NaoTrac
[commercial]surgical · food-service · 2 deployments in catalog
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.)
Manufacturer
Brain NaviForm Factor
surgical
Lifecycle
commercial
Operational Reality
Audited
Deployments
2
Target Price
Custom Quote
- SURGICAL
- COMMERCIAL
Description
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.
Key facts & specs
- website
- https://www.prnewswire.com/news-releases/brain-navi-naotrac-us-fda-clearance
- lifecycle
- active
- manufacturer
- Brain Navi
- deployments count
- 2
- Maturity stage
- commercial
- 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
- 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
Safety record
No incidents on record for NaoTrac.
FAQ
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.
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.
Where is NaoTrac deployed?
2 verified deployments of NaoTrac are on the DEPLOY registry, including at Spain, Rotterdam.
Can you buy NaoTrac?
NaoTrac is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.
Is NaoTrac FDA cleared?
NaoTrac has 1 regulatory record on the DEPLOY registry: FDA 510(k) clearance (K242575), cleared. See the Regulatory filings section for each agency source.
What are alternatives to NaoTrac?
On the DEPLOY registry, comparable surgical robots to NaoTrac include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.
How does NaoTrac compare to da Vinci (and Ion)?
NaoTrac and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. NaoTrac has 2 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
Is NaoTrac a top surgical?
On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, NaoTrac ranks in roughly the top 67% of surgical models tracked by the registry.
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.
Is NaoTrac safe?
NaoTrac has no incidents on record in the DEPLOY registry. This does not constitute a safety guarantee; it reflects the incidents DEPLOY has tracked and verified to date.