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  "documentTitle": "iRhythm Technologies, Inc. (IRTC)",
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  "presentationDate": "2025-08-18 00:00:00",
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      "text": "We believe Blackford's communications and iRhythm's actions are very concerning given his 25-year career in the medical device industry, including employment at another company that received an FDA warning letter for misbranding.",
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      "text": "CEO Blackford was employed by NuVasive from 2009 to 2017. In March 2013, while Blackford served as EVP of Finance and Investor Relations, NuVasive received an FDA warning letter for marketing its Affix Spinous Process Plate System for uses not approved by the FDA. Later, NuVasive faced a qui tam lawsuit brought by the DOJ (United States ex rel. Kevin Ryan v. NuVasive, Inc.) for marketing its CoRoent System for unapproved uses as well as paying kickbacks to physicians. NuVasive paid a $13.5 million fine to settle the case in July 2015 when Blackford was the Company's CFO. In addition, iRhythm's CFO from 2022 to 2024 Bobzien also worked at NuVasive from 2013 to 2017.",
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      "kind": "quote",
      "text": "The Justice Department is committed to holding medical device manufacturers accountable, which includes requiring that they follow all laws designed to ensure that medical devices are safe and effective — Benjamin C. Mizer, Principal Deputy Assistant Attorney General.",
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      "kind": "title",
      "text": "How Could Blackford Downplay Labeling Violations After His Experience At NuVasive?",
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