{
  "release_id": "73130c34862e2d06",
  "id": "cardio:apple-irregular-rhythm-notification",
  "owner": "cardio",
  "kind": "product",
  "slug": "apple-irregular-rhythm-notification",
  "name": "Irregular Rhythm Notification Feature (Apple)",
  "aliases": [
    "Apple Irregular Rhythm Notification Feature",
    "Irregular Rhythm Notification Feature"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "An Apple feature that FDA names the Irregular Rhythm Notification Feature. The US Food and Drug Administration granted Apple's De Novo request for it in September 2018, and names its device type photoplethysmograph analysis software for over-the-counter use. The FDA records read do not describe what the feature does or who it is for. The Apple Heart Study tested a smartwatch alert for an irregular pulse: 34% of notified participants who returned an analyzable ECG patch had atrial fibrillation on it. That study used its own research app, and the sources read do not say how it relates to this feature.",
  "summary_technical": "FDA De Novo DEN180042, decided 2018-09-11 (received 2018-08-09), applicant Apple, Inc. (the FDA database page calls it the requester). Product code QDB, class 2, regulation number 870.2790; FDA's device-type name for the code is photoplethysmograph analysis software for over-the-counter use. The openFDA record gives no indications-for-use text, no model and no version. The openFDA registration and listing records name Apple Inc. as a manufacturing establishment for the feature under DEN180042; that listing is current and does not show who made it in 2018. The registry intervention of the Apple Heart Study is the study's own app and not this feature.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [],
  "navigation": {
    "cardio": {
      "condition-area": [
        "arrhythmias"
      ]
    }
  },
  "payload": {
    "subtype": "software",
    "model_or_formulation": "Irregular Rhythm Notification Feature",
    "version": "Not stated in the FDA records",
    "intended_use_snapshots": []
  },
  "content_digest": "9a7db6e38e334629f608d0e936a879ea6235112ccd9f56f6151cb19bdf1cdc76",
  "review": {
    "content_digest": "9a7db6e38e334629f608d0e936a879ea6235112ccd9f56f6151cb19bdf1cdc76",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [
    {
      "release_id": "73130c34862e2d06",
      "id": "cardio:claim-fda-den180042-granted",
      "owner": "cardio",
      "subject_entity_id": "cardio:apple-irregular-rhythm-notification",
      "category": "regulatory",
      "statement": "The US Food and Drug Administration granted De Novo request DEN180042 for the Irregular Rhythm Notification Feature on 11 September 2018, after receiving it on 9 August 2018. The openFDA record names Apple, Inc. as applicant and gives product code QDB, device class 2 and regulation number 870.2790. It gives the FDA product-code device name as photoplethysmograph analysis software for over-the-counter use. The FDA database page gives the decision as granted (DENG) and calls Apple the requester. In the openFDA record the clearance type is Direct and the decision description reads Unknown.",
      "context": {
        "id": "cardio:ctx-fda-den180042-us",
        "label": "United States De Novo record DEN180042 for the Irregular Rhythm Notification Feature",
        "recipient": "unknown",
        "population": "Not stated in the FDA records. They name a feature, an applicant and a product code, and give no intended population.",
        "care_setting": "Not stated in the FDA records",
        "geography": "United States (decision by the US Food and Drug Administration)",
        "life_stage_note": "Not stated in the FDA records",
        "life_stage_terms": null,
        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable (regulatory decision)",
        "eligibility": {
          "inclusion": [],
          "exclusion": []
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "The fetched records give no indications-for-use text, so the intended population and use are not stated here. A De Novo grant is a regulatory decision about a device type. It is not a finding about how accurate the feature is for any person or in everyday use. The Apple Heart Study tested the study's own research app, and the sources read do not say how it relates to the authorized feature, so the study is not evidence about this feature. openFDA data are unvalidated, and the decision description field reads Unknown.",
      "editorial_state": "draft",
      "checked_at": "2026-10-14",
      "next_review_due": null,
      "valid_from": null,
      "valid_to": null,
      "citations": [
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