Zio ECG Utilization Service
Description
The Zio ECG Utilization Service (ZEUS) System is intended to analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring.
Detailed example
After patient monitoring by Zio XT or Zio AT Patch, a final report is generated based on the beat-to-beat information from the entire ECG recording. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety and patients who are asymptomatic. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.
AI / analytics pattern
Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relationships.
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Support diagnoses. It downloads, stores, analyzes and aggregates the electrocardiogram (ECG) data for a Certified Cardiographic Technician (CCT) to review and generate a report of the findings contained within the data. This enables the provision of a complete ECG processing and analysis service. Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns.
Controls / human review
ATO: Not reported; PIA: Not published