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  "documentTitle": "iRhythm Technologies, Inc. (IRTC)",
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  "authorName": "Spruce Point Capital Management",
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  "presentationDate": "2025-08-18 00:00:00",
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      "text": "Excerpts From FDA Warning Letter Dated 5/25/23 (CMS 643474)",
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      "text": "Shockingly, two patients died while wearing Zio AT devices that had reached their transmission limit and thus failed to notify their physicians.",
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      "text": "FDA finds the Zio AT has an uncommunicated device transmission limit... FDA finds incomplete patient registration can lead to failure to capture patient data... FDA finds that neither issue was properly communicated to patients or physicians",
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      "text": "In both its August 2022 Form 483 and May 2023 Warning Letter, the FDA observed two potentially fatal flaws in iRhythm’s Zio AT product and how it is managed: (1) that the device had a maximum event transmission limit after which it ceased transmitting any data to its ZEUS System, and (2) that if the patient registration was incomplete the product would not transmit data as intended. Both of these problems could prevent timely physician notification of potentially life-threatening cardiac events.",
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      "text": "As a [redacted], your firm implemented a transmission limit on how many times the Zio AT System transmits data. As a result, the device is only able to transmit 100 patient-triggered and 500 automatically detected arrhythmia events. Once the transmission limit is reached, the patient's data stops being transmitted for review/reporting. Thus, when the transmission limit is hit, the device can no longer be used for its intended purpose of transmitting patient ECG for reporting. Further, when the transmission limit is hit, the device can no longer provide near-real time monitoring for high-risk patients. — FDA Warning Letter Dated 5/25/23 (CMS 643474)",
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      "kind": "title",
      "text": "The FDA Warned iRhythm That Its Zio AT Product Is Jeopardizing Patient Safety",
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