{"id":"f9d455c1-678b-4cf4-9a7d-37f593be85bc","companyId":"6b7cdf14-0d84-456b-9374-55f9498fbd84","modelName":"NaoTrac","slug":"brain-navi-naotrac","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.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"Verified","value":"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)."},{"label":"Autonomy spectrum (notable)","value":"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."},{"label":"Maturity = commercial / early-commercial","value":"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."},{"label":"Cap-flag","value":"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).","formFactor":"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"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.prnewswire.com/news-releases/brain-navi-naotrac-us-fda-clearance","title":"Brain Navi achieves US FDA clearance for neurosurgical robot NaoTrac (Jun 2025)","sourceName":"Brain Navi (PR Newswire)"},{"url":"https://www.prnewswire.com/news-releases/tfda-approves-naotrac-autonomous-neurosurgical-robot","title":"TFDA approves NaoTrac autonomous neurosurgical navigation robot (Jul 2022)","sourceName":"Brain Navi (PR Newswire)"},{"url":"https://www.biospectrumasia.com/news/brain-navi-naotrac","title":"Brain Navi (Taiwan; founded 2015; NaoTrac neurosurgical navigation robot)","sourceName":"BioSpectrum Asia"}],"aliases":["NaoTrac","Brain Navi NaoTrac"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"Form factor","value":"surgical (neurosurgical navigation robot with robotic arm)"},{"label":"Autonomy level","value":"AI-driven non-contact frameless registration is autonomous; autonomy is in navigation/registration step, not autonomous cutting or tissue manipulation"},{"label":"Regulatory approval","value":"TFDA approval July 2022, CE mark, US FDA 510(k) clearance June 2025 (cleared as stereotaxic guiding device)"},{"label":"Maturity","value":"commercial / early-commercial; multi-jurisdiction cleared but small startup with limited and unverified installed base"}],"createdAt":"2026-06-03T20:13:34.907Z","updatedAt":"2026-07-12T04:24:54.291Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null,"jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/brain-navi-naotrac","url":"https://registry.deploy.report/models/brain-navi-naotrac","name":"NaoTrac","alternateName":["NaoTrac","Brain Navi NaoTrac"],"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.","identifier":"f9d455c1-678b-4cf4-9a7d-37f593be85bc","category":"surgical","publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":"commercial","lifecycle_state":"active","architectural_position":{"cohort":"surgical","sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":3,"primary_source_types":["primary-company-ir"]}}}