{"id":"82dc903d-01e7-4b6b-abdc-75a66c225124","modelId":"f9d455c1-678b-4cf4-9a7d-37f593be85bc","versionId":null,"locationId":"3819a750-7a3b-4af9-ba4c-293a843dc8e3","operatorId":null,"ownerId":null,"slug":"brain-navi-naotrac-spain","status":"operational","firstSeen":"2025-08-11T00:00:00.000Z","statusChangeReason":null,"sourceQualityTier":null,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.prnewswire.com/apac/news-releases/brain-navi-biotechnologys-naotrac-performs-first-surgeries-in-spain-302523915.html","label":"Brain Navi Biotechnology's NaoTrac performs first surgeries in Spain","title":"Brain Navi Biotechnology's NaoTrac performs first surgeries in Spain","mediaType":"article","publishedAt":"2025-08-11"}],"notes":"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 performed. The deployment was facilitated through Palex Healthcare, Brain Navi's distribution partner in Spain. Hospital name not publicly disclosed in available sources.","keyFacts":[{"label":"Distribution partner","value":"Palex Healthcare (Spain)"},{"label":"Entry event","value":"SENEC Congress demonstration"},{"label":"First surgeries","value":"August 2025"}],"reviewNote":null,"exposureHours":null,"exposureBasis":null,"customerSegment":null,"scaleTier":null,"contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-06-11T14:07:20.796Z","updatedAt":"2026-06-12T00:12:53.631Z","model":{"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","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)"},"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,"createdAt":"2026-06-03T20:13:34.907Z","updatedAt":"2026-06-03T20:13:34.907Z","company":{"id":"6b7cdf14-0d84-456b-9374-55f9498fbd84","name":"Brain Navi","slug":"brain-navi","description":"Taiwanese neurosurgical-robotics startup (Zhubei; founded 2015) making the NaoTrac navigation robot (robotic arm + autonomous registration); TFDA 2022, CE, US FDA 510(k) Jun 2025.","status":"private","founded":2015,"hq":"Zhubei, Taiwan","fundingTotal":null,"type":"both","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"}],"keyFacts":[{"label":"Product","value":"NaoTrac neurosurgical navigation robot (robotic arm + autonomous registration)."},{"label":"Gating events","value":"TFDA Jul 2022; CE mark; US FDA 510(k) Jun 2025."}],"aliases":["Brain Navi Biotechnology","NaoTrac"],"collisionRisk":"low","reviewNote":null,"createdAt":"2026-06-03T20:13:34.142Z","updatedAt":"2026-06-03T20:13:34.142Z"}},"version":null,"location":{"id":"3819a750-7a3b-4af9-ba4c-293a843dc8e3","name":"Spain","slug":"spain","kind":"country","parentLocationId":null,"region":null,"lat":null,"lng":null,"reviewStatus":"reviewed","aliases":["ES"],"collisionRisk":"high","reviewNote":null,"createdAt":"2026-05-31T12:24:06.679Z","updatedAt":"2026-05-31T12:24:06.679Z"},"operator":null,"owner":null,"derived":{"trustTier":"unverified","currentPosture":null},"jsonLd":{"@context":"https://schema.org","@type":"Event","@id":"https://registry.deploy.report/deployments/brain-navi-naotrac-spain","url":"https://registry.deploy.report/deployments/brain-navi-naotrac-spain","name":"NaoTrac at Spain","identifier":"82dc903d-01e7-4b6b-abdc-75a66c225124","startDate":"2025-08-11T00:00:00.000Z","location":{"@type":"Place","@id":"https://registry.deploy.report/locations/spain","name":"Spain"},"organizer":{"@type":"Organization","@id":"https://registry.deploy.report/companies/brain-navi","name":"Brain Navi"},"about":{"@type":"Product","@id":"https://registry.deploy.report/models/brain-navi-naotrac","name":"NaoTrac"},"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":1,"primary_source_types":[]}}}