iRhythm cited for unapproved claims, MDR and QSR issues

The US Food and Drug Administration (FDA) on Tuesday released a warning letter it sent to iRhythm Technologies late last month for making unapproved claims about its remote heart monitoring devices.

The company first publicly acknowledged the warning letter in a filing to the US Securities and Exchange Commission on 30 May, five days after the warning letter is dated. The warning letter provides more details on the types of violations the company has been accused of by the agency and their severity.

Several law firms are reportedly investigating whether the firm violated securities laws by not properly disclosing the matter to investors.

According to the warning letter, FDA investigators found that iRhythm’s Zio AT System, which is indicated to remotely monitor cardiac events, is being marketed beyond the use that it was cleared for. FDA notes that the Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. The device transmits data on arrythmias both triggered by patients and automatically to a monitoring center for further analysis.

While the device is indicated for adults who are non-critical for arrythmia, FDA said the company’s marketing materials and website claim it can be used for “near real-time monitoring” as a “mobile cardiac telemetry monitor,” that can provide notifications “immediately,” and that it is intended for “high-risk patients.”

“Your firm’s labeling describes a new patient population, for example, by using the term ‘near real-time reporting’ and ‘high-risk,’ instead of non-critical care,” said FDA. “This change could significantly affect the safety or effectiveness of the device because it suggests that the device is intended for a new patient population – high-risk patients.”

“High risk patients need near real-time monitoring because they are more likely to have a life-threatening arrhythmia, which requires timely treatment to prevent serious injury or death,” the agency added. “Accordingly, these changes required the submission of a new 510(k).”

FDA also said iRhythm did not follow Quality System Regulation (QSR) requirements because it failed to adequately establish and maintain corrective and preventive actions (CAPA) and failed to conduct a health hazard evaluation (HHE) as required by existing CAPA procedures.

iRhythm was also cited for failing to submit MDRs to FDA within 30 days of becoming aware of injuries and deaths that may reasonably have been caused by the device. The agency said the company became aware of at least two events where patients died after using the device in October 2021, but it did not receive the MDRs until almost a year later in September 2022. FDA also cited the firm for failing to adequately develop, maintain and implement written MDR procedures.

FDA has asked iRhythm to respond in writing within 15 business days outlining the steps it’s taking to rectify the violations listed in the warning letter.

“If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities,” said FDA. “If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.”

Following news of the warning letter, several law firms said they are investigating whether iRhythm violated securities laws, including Los Angeles-based Schall Law Firm, and New York-Based firms Pomerantz Law Firm and Bronstein, Gewirtz & Grossman, LLC.

iRhythm cited for unapproved claims, MDR and QSR issues

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