Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

The Zio® ECG Utilization Service (ZEUS) System is a programmable diagnostic computer designed to analyze continuous single-lead ECG data from Zio Patches for long-term cardiac monitoring in adult patients. Its methodology combines automated beat-to-beat ECG analysis with review by a Certified Cardiographic Technician to generate comprehensive reports for clinicians, aiding in the diagnosis of symptomatic and asymptomatic cardiac events.

The Zio® ECG Utilization Service (ZEUS) System, developed by iRhythm Technologies, Inc., is a programmable diagnostic computer designed for the long-term monitoring, analysis, and reporting of cardiac events. It processes continuous, single-lead electrocardiogram (ECG) data acquired from patients using Zio XT or Zio AT Patches. The system is indicated for use in adults aged 18 years or older who may be asymptomatic or experiencing transient symptoms such as palpitations, shortness of breath, dizziness, or syncope, but is not intended for use in critical care settings. The ZEUS System's methodology involves downloading, storing, analyzing, and aggregating the complete ECG recording to provide beat-to-beat information. Automated ECG analysis is performed, with quantified sensitivity and positive predictivity levels meeting specified requirements. Following this automated processing, a Certified Cardiographic Technician (CCT) reviews the data and generates a final report. This comprehensive report is then provided to the prescribing clinician, who uses it in conjunction with their clinical judgment and experience to render a diagnosis.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What are the specific sensitivity and positive predictivity values for the automated ECG analysis algorithms in the ZEUS System across various common arrhythmias?; How does the ZEUS System differentiate its analysis or reporting when data is sourced from a Zio XT Patch versus a Zio AT Patch, given their potentially different monitoring durations or capabilities?; What is the typical turnaround time from the completion of patient monitoring with a Zio Patch to the delivery of the final CCT-reviewed report to the clinician?; What cybersecurity measures, beyond adherence to guidance, are implemented within the ZEUS System to protect patient ECG data during download, storage, analysis, and transmission?; Are there any specific patient populations (e.g., those with certain comorbidities or on specific medications) for whom the ZEUS system's automated analysis might have known limitations or require more intensive CCT review?