{"id":"83dd2bce-db19-46f5-a38b-d3b3c59af83b","companyId":"c5bc5b03-fac1-4555-a5aa-70a2428f26b5","modelName":"Connexus BCI","slug":"paradromics-connexus-bci","description":"Fully implantable high data-rate brain-computer interface designed to restore speech and computer control for severely motor-impaired patients.","formFactor":"biometric","industryVertical":"healthcare","environment":"indoor","maturityStage":"pilot","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://paradromics.com/news/paradromics-receives-fda-approval-for-the-connect-one-clinical-study-with-the-connexus-brain-computer-interface/","title":"Paradromics Receives FDA Approval for the Connect-One Clinical Study with the Connexus BCI","sourceName":"Paradromics"},{"url":"https://paradromics.com/news/paradromics-completes-first-human-brain-computer-interface-bci-implantation/","date":"2026-06-17","title":"Paradromics Completes First Connexus BCI Human Implant","sourceName":"Paradromics"},{"url":"https://clinicaltrials.gov/study/NCT07357428","title":"CONNECT-ONE: Early Feasibility Study of Connexus BCI (NCT07357428)","sourceName":"ClinicalTrials.gov"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"FDA IDE (company-stated, Nov 2025)","value":"FDA granted IDE approval for the Connect-One early feasibility study of Connexus for speech restoration and computer control in severe motor impairment."},{"label":"Study registry (ClinicalTrials.gov)","value":"NCT07357428: interventional, sponsored by Paradromics, recruiting, estimated enrollment of 2, across UC Davis, Massachusetts General Hospital and Univ. of Michigan."},{"label":"First implant (company-stated, Jun 2026)","value":"Done at University of Michigan Health by Matthew Willsey, M.D., Ph.D., with Aditya S. Pandey, M.D., for a participant with motor neuron disease."},{"label":"Follow-up (company-stated)","value":"Planned six-year follow-up for the first implant participant."}],"createdAt":"2026-08-08T22:30:25.718Z","updatedAt":"2026-10-10T03:47:26.428Z","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/paradromics-connexus-bci","url":"https://registry.deploy.report/models/paradromics-connexus-bci","name":"Connexus BCI","description":"Fully implantable high data-rate brain-computer interface designed to restore speech and computer control for severely motor-impaired patients.","identifier":"83dd2bce-db19-46f5-a38b-d3b3c59af83b","category":"biometric","publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":"pilot","lifecycle_state":"active","architectural_position":{"cohort":"biometric","sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":3,"primary_source_types":[]}}}