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  "documentTitle": "iRhythm Technologies, Inc. (IRTC)",
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      "text": "Excerpts From FDA Warning Letter Dated 5/25/23 (CMS 643474)",
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      "text": "For brevity, we note that iRhythm’s initial responses (including that the transmission limit was a “design limitation” rather than a “nonconformance”) were both deemed inadequate by the FDA.",
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      "text": "FDA findings regarding transmission limit (2019) and registration completion (2017) issues, citing specific patient harm and internal awareness.",
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      "text": "To make matters worse, the FDA observed that iRhythm knew about the transmission limit and registration issues since 2019 and 2017, respectively. As a result, numerous patients suffered arrhythmias while wearing the Zio AT without their physicians receiving the intended timely notification.",
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      "text": "For brevity, we note that iRhythm’s initial responses (including that the transmission limit was a “design limitation” rather than a “nonconformance”) were both deemed inadequate by the FDA. We believe that iRhythm simply couldn’t design a product without transmission limitations that also had adequate battery life to accommodate the stated 14-day wear period.",
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      "text": "Our inspection revealed that your firm knew that the device’s transmission limit, which was explained in the previous section, was resulting in data not being transmitted. Records reviewed during our inspection indicate that your firm has been aware of customer complaints related to this issue since at least 2019. Specifically, our inspection found a significant number of complaints regarding this issue, which revealed two deaths as well as significant arrythmias that were not reported to physicians. — FDA Warning Letter",
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      "text": "Source: FDA Warning Letter dated 5/25/23 (CMS# 643474)",
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      "kind": "title",
      "text": "Shockingly, The FDA Observed iRhythm Knew About These Issues For Years And Failed To Address Them",
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