{
  "schemaVersion": "2.0.0",
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    "manufacturerSlug": "precision-neuroscience",
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      "value": "Layer 7 Cortical Interface",
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        {
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      ],
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        {
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      ],
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      "status": "unknown",
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    },
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        "Layer 7 Cortical Electrode"
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        {
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      ],
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      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "predecessorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "successorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "tagline": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "shortDescription": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial prose"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "longDescription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "countryOfOrigin": {
      "value": "US",
      "status": "verified",
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        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
          "label": "FDA 510(k) K242618 — Layer 7-T (Precision Neuroscience, Corp.)",
          "date": "2025-03-30"
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      ],
      "updatedAt": "2026-05-04"
    },
    "releaseDate": {
      "value": "2025-03-30",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
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      ],
      "updatedAt": "2026-05-04"
    },
    "announcedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
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    "discontinuedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "status": {
      "value": "clinical-trial",
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          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
          "label": "GlobeNewswire — Precision Neuroscience FDA clearance press release",
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      "updatedAt": "2026-05-04"
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        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
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      ],
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        {
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        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
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      ],
      "updatedAt": "2026-05-04"
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      ],
      "updatedAt": "2026-05-04"
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        {
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        },
        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
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      ],
      "updatedAt": "2026-05-04"
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        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
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      ],
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      ],
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        {
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        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
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      ],
      "updatedAt": "2026-05-04"
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    "targetUsers": {
      "value": [
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        "patient-spinal-cord-injury",
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        "patient-als",
        "patient-paralysis"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242618.pdf",
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          "date": "2025-03-30"
        },
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
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  },
  "electrodes": {
    "totalChannels": {
      "value": 1024,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
          "label": "GlobeNewswire — Precision Neuroscience FDA clearance press release",
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        },
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "recordingChannels": {
      "value": 1024,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
          "label": "GlobeNewswire — Precision Neuroscience FDA clearance press release",
          "date": "2025-04-17"
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        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
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      ],
      "updatedAt": "2026-05-04"
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    "referenceChannels": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "electrodeType": {
      "value": [
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      "status": "verified",
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        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
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          "date": "2025-03-30"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "material": {
      "value": [
        "thin-film-polyimide",
        "platinum"
      ],
      "status": "verified",
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        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
          "label": "GlobeNewswire — Precision Neuroscience FDA clearance press release",
          "date": "2025-04-17"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "positions1020": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "channels": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "requiresGel": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
          "label": "FDA 510(k) K242618 — Layer 7-T (Precision Neuroscience, Corp.)",
          "date": "2025-03-30"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "requiresSaline": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
          "label": "FDA 510(k) K242618 — Layer 7-T (Precision Neuroscience, Corp.)",
          "date": "2025-03-30"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "prepTimeMinutes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "reusable": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
          "label": "FDA 510(k) K242618 — Layer 7-T (Precision Neuroscience, Corp.)",
          "date": "2025-03-30"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "disposable": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242618",
          "label": "FDA 510(k) K242618 — Layer 7-T (Precision Neuroscience, Corp.)",
          "date": "2025-03-30"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "acquisition": {
    "samplingRateHz": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "resolutionBits": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notchFiltersHz": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "onboardArtifactRejection": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "stimulation": {
    "capable": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242618.pdf",
          "label": "FDA 510(k) K242618 clearance letter (PDF)",
          "date": "2025-03-30"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "connectivity": {
    "protocols": {
      "status": "unknown",
      "sources": [
        {
          "label": "device is wired to external acquisition equipment via headstage; specific protocols not disclosed"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "bluetoothVersion": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "bluetoothProfiles": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "concurrentMode": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "encryptionInTransit": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "pairingMethods": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudSync": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineRecording": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "power": {
    "sources": {
      "value": [
        "wired-usb"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "batteryLifeActiveHours": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingPort": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingTimeMinutes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "batteryReplaceable": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "value": "Powered by external recording equipment via the headstage.",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "physical": {
    "weightGrams": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dimensions": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "materials": {
      "value": [
        "thin-film-polyimide",
        "platinum"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
          "label": "GlobeNewswire — Precision Neuroscience FDA clearance press release",
          "date": "2025-04-17"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "sizes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "headCircumferenceCm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "operatingTempC": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "compute": {
    "hasOnboardComputer": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "operatingSystems": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "primaryOs": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "edgeMlAccelerator": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "rootAccessLevel": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "appSandbox": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "thirdPartyAppsAllowed": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "value": "Passive array + headstage; computation runs on host-side equipment.",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "software": {
    "apps": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "mobileApp": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudPlatform": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineMode": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscriptionRequired": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rawDataAccess": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.medtechdive.com/news/precision-neuroscience-brain-implant-fda-cleared/745913/",
          "label": "MedTech Dive — Precision FDA clearance coverage"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "exportFormats": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "lslSupport": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dataOwnership": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "privacyPolicyUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "sdk": {
    "hasSdk": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "docsUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "openSource": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "languages": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "webBluetooth": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rawSampleAccess": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "bciParadigms": {
      "value": [
        "decoded-speech",
        "cursor-control",
        "click-decoder",
        "motor-imagery"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
          "label": "GlobeNewswire — Precision Neuroscience FDA clearance press release",
          "date": "2025-04-17"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "thirdPartyIntegrations": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "capabilities": {
    "attentionFocus": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "meditationCalm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "neurofeedback": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "meditationCoaching": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "sleepTracking": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "customCapabilities": {
      "value": [
        {
          "name": "Intra-operative high-resolution cortical mapping",
          "description": "Used in 37+ clinical participants prior to the 510(k) clearance through partnerships with Beth Israel Deaconess, WVU's Rockefeller Neuroscience Institute, Penn Medicine, and Mount Sinai.",
          "evidenceLevel": "fda-cleared"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html",
          "label": "GlobeNewswire — Precision Neuroscience FDA clearance press release",
          "date": "2025-04-17"
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      },
      {
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  }
}