{"id":"e30d055e-849c-4881-83ff-6b3415172402","slug":"nia-therapeutics-fda-breakthrough-device-2026","kind":"regulatory_action","headline":"FDA grants Breakthrough Device Designation for NIA Therapeutics memory restoration implant","summary":"The FDA granted Breakthrough Device Designation to NIA Therapeutics' Smart Neurostimulation System (SNS) for traumatic brain injury-related memory loss — the first device ever to earn this designation for TBI memory loss. The implantable BCI records from 60 channels across 4 brain regions and delivers closed-loop stimulation to restore memory encoding.","occurredAt":"2026-03-01T00:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"2dd92afc-8a32-4c63-b5ad-b45fd0afeb88","dataCenterId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"other","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-08-21T18:47:48.915Z","updatedAt":"2026-08-23T15:14:15.796Z","model":null,"deployment":null,"company":{"id":"2dd92afc-8a32-4c63-b5ad-b45fd0afeb88","name":"Nia Therapeutics","slug":"nia-therapeutics","description":"Nia Therapeutics (Nia TX) is a San Francisco-based brain-computer interface company developing an AI-guided brain implant for memory loss. Its [Smart Neurostimulation System (SNS)](/models/nia-smart-neurostimulation-system) uses closed-loop neurostimulation to improve memory in patients with traumatic brain injury and cognitive disorders. FDA Breakthrough Device Designation granted; first device to receive this designation for memory loss. 60-channel wireless AI-enabled platform validated in vivo.","status":"private","founded":0,"hq":"San Francisco, California, USA","hqLat":37.7879363,"hqLng":-122.4075201,"hqGeocodedAt":"2026-08-23T21:32:23.624Z","hqAddress":null,"hqPrecision":null,"website":"https://www.niatx.com","fundingTotal":null,"type":"hardware","roles":["robot_maker","robot_operator"],"reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":"[{\"url\":\"https://niatherapeutics.com/\",\"title\":\"Nia Therapeutics — Smart neurostimulation for memory recovery\",\"sourceName\":\"Nia Therapeutics (official)\"},{\"url\":\"https://niatherapeutics.com/media-hub/nia-therapeutics-receives-fda-breakthrough-device-designation-for-brain-implant\",\"title\":\"Nia Therapeutics receives FDA breakthrough device designation for brain implant\",\"sourceName\":\"Nia Therapeutics (official)\"}]","keyFacts":[{"label":"Headquarters","value":"San Francisco, California, USA"},null,{"label":"Status","value":"private"},{"label":"Type","value":"hardware"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-08-08T22:26:46.607Z","updatedAt":"2026-08-21T22:25:31.322Z"},"derived":{"status":"active"},"sources":[{"id":"870d13da-d20e-4a43-9d5b-edbf69b8858a","incidentId":"e30d055e-849c-4881-83ff-6b3415172402","url":"https://www.fda.gov/","label":null,"publishedAt":null,"notes":null,"title":"FDA Breakthrough Device Designation — NIA Therapeutics SNS","sourceName":null,"mediaType":"news","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-21T18:47:49.306Z","updatedAt":"2026-08-21T18:47:49.306Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/nia-therapeutics-fda-breakthrough-device-2026","url":"https://registry.deploy.report/incidents/nia-therapeutics-fda-breakthrough-device-2026","headline":"FDA grants Breakthrough Device Designation for NIA Therapeutics memory restoration implant","description":"The FDA granted Breakthrough Device Designation to NIA Therapeutics' Smart Neurostimulation System (SNS) for traumatic brain injury-related memory loss — the first device ever to earn this designation for TBI memory loss. The implantable BCI records from 60 channels across 4 brain regions and delivers closed-loop stimulation to restore memory encoding.","identifier":"e30d055e-849c-4881-83ff-6b3415172402","datePublished":"2026-03-01T00:00:00.000Z","articleSection":"regulatory action","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":["primary-fda-database"]}}}