Loading…
iRhythm Technologies, Inc. was cited for manufacturing the Zio AT System, a cardiac monitoring device intended for diagnosing heart arrhythmias, in violation of FDA Quality System Regulation (QSR) requirements and for operating with unapproved device components. During an FDA inspection of the company's Cypress, California facility in July-August 2022, investigators identified multiple compliance failures documented on Form FDA 483, with the company submitting responses across eight months (September 2022 through March 2023) that the FDA found inadequate to address the noted violations. The warning specifically highlighted that the Zio AT System, including its ZEUS software component used for ECG capture and arrhythmia analysis, was being distributed without proper regulatory clearance, despite the company holding clearance only for the separate Zio QX ECG Monitoring device.