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  "documentTitle": "iRhythm Technologies, Inc. (IRTC)",
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      "text": "We believe it is damning that iRhythm failed to submit MDR reports related to an issue that could cause patient deaths given that MDR reporting failures were already an FDA criticism in its 2023 Warning Letter. Collecting, analyzing, and remediating complaints is one of the most fundamental activities of any medical device company.",
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      "text": "We believe it is damning that iRhythm failed to submit MDR reports related to an issue that could cause patient deaths given that MDR reporting failures were already an FDA criticism in its 2023 Warning Letter.",
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      "text": "FDA finds over 4,000 complaints related to the accuracy of its data analysis and reporting. FDA finds that iRhythm failed to investigate the complaints. FDA notes that iRhythm failed to submit MDR reports despite the potential for patient death.",
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      "text": "In its Form 483 (San Francisco) dated 7/31/24, the FDA clearly states that iRhythm failed to properly analyze over 4,000 complaints related to recurring quality issues involving the misreading and/or misclassification of data used for diagnostic purposes. The FDA detailed the ways that iRhythm sought to conceal these complaints and their implications for patient safety.",
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      "text": "“...your firm received approximately 4,014 complaints related to your Certified Cardiographic Technician (CCT) personnel operations from 05/02/2022 to 07/19/2024, including issues/ events related to CCT personnel misreading arrhythmia data and providing such misclassified data to end users for diagnosis purposes.” — FDA Form 483 dated 7/31/24 (San Francisco); “You also have not initiated any corrective and preventive actions to investigate the cause or identify the action(s) needed to correct and prevent recurrence of this quality problem...You have not evaluated the risk associated with your Certified Cardiographic Technician (CCT) personnel operations to ensure that your Zio AT, Zio XT, Zio Monitor, and Zeus System Software medical devices conform to defined user needs and intended uses.” — FDA Form 483 dated 7/31/24 (San Francisco); “you routinely do not report required information after becoming aware of events that allege your Zio AT, Zio XT, Zio Monitor, and Zeus System Software medical devices have malfunctioned and would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.” — FDA Form 483 dated 7/31/24 (San Francisco)",
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      "text": "The FDA Shows That iRhythm Knew Of Thousands Of Complaints Regarding The Misreading Of Zio AT Data But Failed To Take Action",
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