{
  "schemaVersion": "2.0.0",
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    "manufacturerSlug": "neuronetics",
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      "value": "NeuroStar TMS Therapy System",
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        {
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          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
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        }
      ],
      "updatedAt": "2026-05-04"
    },
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      "value": "Model 1.1",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
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        }
      ],
      "updatedAt": "2026-05-04"
    },
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      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "aliases": {
      "value": [
        "NeuroStar",
        "NeuroStar Advanced Therapy"
      ],
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      "sources": [
        {
          "url": "https://neurostar.com",
          "label": "NeuroStar — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "generation": {
      "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",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
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        }
      ],
      "updatedAt": "2026-05-04"
    },
    "releaseDate": {
      "value": "2008-12-16",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
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        }
      ],
      "updatedAt": "2026-05-04"
    },
    "announcedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "discontinuedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "status": {
      "value": "shipping",
      "status": "verified",
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        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
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        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
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      "value": [
        "TMS"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
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        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
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        }
      ],
      "updatedAt": "2026-05-04"
    },
    "direction": {
      "value": "write",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "category": {
      "value": [
        "therapeutic",
        "stimulation",
        "clinical-grade"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "formFactor": {
      "value": [
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      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "intendedUseCases": {
      "value": [
        "outpatient TMS therapy for treatment-resistant major depression",
        "OCD adjunctive treatment",
        "adolescent (15+) major depression",
        "anxious depression"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
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        },
        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    },
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        "clinician",
        "patient-depression"
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      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "stimulation": {
    "capable": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "connectivity": {
    "protocols": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 had ethernet/USB/WiFi; not in primary cited sources"
        }
      ],
      "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-mains"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "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": "Mains-powered floor unit — no battery.",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
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        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "physical": {
    "weightGrams": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dimensions": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "materials": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "sizes": {
      "value": [
        "clinic-floor-unit"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "headCircumferenceCm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "operatingTempC": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "compute": {
    "hasOnboardComputer": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "operatingSystems": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "primaryOs": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "edgeMlAccelerator": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rootAccessLevel": {
      "value": "none",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "appSandbox": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "thirdPartyAppsAllowed": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "software": {
    "apps": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "mobileApp": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudPlatform": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.neuronetics.com",
          "label": "Neuronetics — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "offlineMode": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscriptionRequired": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rawDataAccess": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "exportFormats": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "lslSupport": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "dataOwnership": {
      "value": "manufacturer",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "privacyPolicyUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "sdk": {
    "hasSdk": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "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": {
      "status": "unknown",
      "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": "FDA-cleared rTMS for major depression",
          "description": "First-in-class FDA-cleared TMS therapy for adults with treatment-resistant major depressive disorder. Subsequent labels extend to OCD, anxious depression, and adolescent depression.",
          "evidenceLevel": "fda-cleared"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
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          "date": "2008-12-16"
        },
        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "security": {
    "authenticationFactors": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "perUserProfiles": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "requiresAccount": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "claimingMethods": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "ownershipModel": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "activationLock": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "remoteLock": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "remoteWipe": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "findMyDevice": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "firmware": {
    "otaSupported": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "otaTransports": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "updateMechanism": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "updateChannels": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "rollbackSupported": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "signedUpdates": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "forcedUpdates": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "userDeferrable": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "updateRequiresAppCompanion": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "averageUpdateFrequency": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "regulatory": {
    "fdaStatus": {
      "value": "510k",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "ceMark": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "certifications": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "prescriptionRequired": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538",
          "label": "FDA 510(k) K083538 — NeuroStar TMS Therapy System Model 1.1 (Neuronetics, Malvern PA)",
          "date": "2008-12-16"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "pediatricApproved": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "pricing": {
    "msrp": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 had $95k as approximate clinic capital purchase price; not on a single primary source"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "currentPrice": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "buyUrls": {
      "value": [
        {
          "region": "global",
          "vendor": "Neuronetics",
          "url": "https://www.neuronetics.com"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.neuronetics.com",
          "label": "Neuronetics — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "warranty": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "returnPolicyDays": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "accessibility": {
    "works_with_hair": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "worksOverGlasses": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "worksOverHeadwear": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "languages": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "pediatricMinimumAge": {
      "value": 15,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "media": {
    "officialUrl": {
      "value": "https://neurostar.com",
      "status": "verified",
      "sources": [
        {
          "url": "https://neurostar.com",
          "label": "NeuroStar — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "productPageUrl": {
      "value": "https://www.neuronetics.com/neurostar-system",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.neuronetics.com/neurostar-system",
          "label": "Neuronetics — NeuroStar System product page"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "editorial": {
    "pros": [
      "Largest U.S. installed base — easy to find a clinic that runs it",
      "Most evidence-rich figure-8-coil platform in psychiatry",
      "Adolescent depression label (ages 15+)",
      "TrakStar reporting integrates with insurance billing"
    ],
    "cons": [
      "Outpatient clinic-only — not a home-use device",
      "Per-session treatment licensing on top of capital cost",
      "Figure-8 coil reaches less deep cortex than BrainsWay's H-coil",
      "Standard 6-week course is a heavy schedule (5 sessions/week)"
    ],
    "bestFor": [
      "Adults and adolescents 15+ with treatment-resistant major depression",
      "U.S. psychiatry clinics integrating TMS into existing workflows",
      "OCD patients pursuing FDA-cleared neuromodulation"
    ],
    "notFor": [
      "Patients with ferromagnetic implants near the head",
      "Home-use scenarios",
      "Clinics needing deep-cortex H-coil stimulation"
    ],
    "comparableDevices": [
      "brainsway-deep-tms"
    ]
  },
  "provenance": {
    "sources": [
      {
        "label": "NeuroStar — product site",
        "url": "https://neurostar.com"
      },
      {
        "label": "Neuronetics — official site",
        "url": "https://www.neuronetics.com"
      },
      {
        "label": "FDA 510(k) K083538",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083538"
      },
      {
        "label": "FDA K083538 510(k) summary",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf8/K083538.pdf"
      }
    ],
    "lastReviewedAt": "2026-05-05"
  }
}