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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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      "kind": "callout",
      "text": "For brevity, we do not provide the countless examples of iRhythm making claims regarding the Zio AT, as the FDA clearly stated that such statements were made. As a result, the FDA considered the Zio AT product inappropriate for high-risk patients and thus mislabeled. And despite the FDA alerting iRhythm to its mislabeling concerns in its August 2022 Form 483, the Company continued to market these devices to high-risk patients. While “mislabeling” may sound like an innocent offense, the implications were potentially fatal for patients and represent a material violation.",
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      "text": "While “mislabeling” may sound like an innocent offense, the implications were potentially fatal for patients and represent a material violation.",
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      "text": "iRhythm did not have FDA approval to market Zio AT as an MCT to high-risk patients. FDA finds that iRhythm failed to report the transmission limitation as a malfunction as required by law.",
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      "text": "The Zio AT came to market under a 510(k) premarket notification application, a simplified clearance process, as the Company claimed it was substantially equivalent to the existing Zio XT device. However, as the FDA noted in its Warning Letter, the Zio XT “is not intended for use on critical care patients”. Seemingly ignoring this fact, iRhythm marketed the Zio AT as a Mobile Cardiac Telemetry (MCT) device capable of “near real time” transmission and timely notification of cardiac events to a patient’s physician, making it appropriate for “high risk” patients. Nor had iRhythm properly reported the transmission limitation as a “malfunction”.",
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      "text": "“...your device was cleared under K163512 for long-term monitoring of arrhythmia events for non-critical care patients where real-time monitoring is not needed as reporting timeliness is not consistent with life-threatening arrhythmias.” — FDA Warning Letter Dated 5/25/23 (CMS 643474)",
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      "text": "Source: FDA Warning Letter dated 5/25/23 (CMS# 643474)",
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      "kind": "title",
      "text": "Patient Risks Were Magnified Because iRhythm Had Been Marketing The Zio AT For High-Risk Patients",
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      "text": "Excerpts From FDA Warning Letter Dated 5/25/23 (CMS 643474)",
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