Zio ECG Utilization Software (ZEUS) System

by iRhythm Technologies  · Based in United States → — Innovating the Future of Cardiac Monitoring
Cardiology Family Medicine Internal Medicine

Contact for pricing
Regulatory Status Disclosed

Overview

The Zio ECG Utilization Software (ZEUS) System by iRhythm Technologies is a sophisticated, cloud-based software solution designed to analyze and report cardiac rhythm data. It is a core component of iRhythm’s end-to-end cardiac monitoring service, which typically includes a wearable Zio monitor (biosensor) that records continuous electrocardiogram (ECG) data for up to 14 days.

ZEUS leverages proprietary deep-learned artificial intelligence (AI) algorithms to detect and classify a wide range of arrhythmias and sinus rhythms from the collected ECG data. This AI-powered analysis is then reviewed and curated by certified cardiographic technicians, who generate a comprehensive end-of-wear report for the prescribing physician.

The system aims to improve diagnostic yield and provider efficiency by offering a longer monitoring period than traditional Holter monitors and providing clinically actionable information. Physicians can access these preliminary findings through the ZioSuite web portal and a dedicated mobile application for review and final interpretation, aiding in arrhythmia diagnosis and management.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI algorithm for arrhythmia detection and classification
  • Continuous ECG data analysis (up to 14 days)
  • Cloud-based data analytics (AWS EC2 platform)
  • Proprietary deep-learned algorithms for enhanced diagnostic accuracy
  • ZioSuite web portal and mobile application for healthcare professionals
  • Comprehensive end-of-wear reports for physician review
  • Integration with Zio wearable biosensors (Zio monitor, Zio Watch)
  • HL7-based EHR integration
  • Secure data handling with multi-factor authentication, encryption, and role-based access controls
  • Patient-triggered event logging for symptomatic episodes

Use Cases

  • Aid in arrhythmia diagnosis and management for patients 18 years or older
  • Long-term continuous ambulatory cardiac monitoring
  • Detection of infrequent or asymptomatic cardiac arrhythmias
  • Monitoring and characterization of atrial fibrillation (AFib)
  • Proactive identification of patients with elevated arrhythmia risk, especially those with comorbid conditions like Type 2 diabetes, CKD, COPD, and CAD

What Physicians Need to Know

ECG/EKG Analysis Capability
The Zio ECG Utilization Software (ZEUS) System stores and analyzes continuous ECG data from compatible cardiac monitoring devices, generating a preliminary, end-of-wear report with beat-to-beat information. It utilizes an AI algorithm for rhythm and beat detection, identifying arrhythmias and sinus rhythms. The system captures and reports symptomatic and asymptomatic cardiac events for long-term monitoring, up to 14 days with the Zio monitor. For the Zio Watch, it employs a continuous photoplethysmography (PPG) and AI-based algorithm to detect and characterize Atrial Fibrillation (AFib) and calculate AFib burden. Certified Cardiographic Technicians (CCTs) review the AI-generated analysis before reports are finalized, which include beats, ectopic runs, ECG segments, rhythms, and heart rate measurements.
Arrhythmia Detection Accuracy
The ZEUS System incorporates proprietary, deep-learned AI algorithms for data analysis. Specifically, the AFib Context Engine (ACE) algorithm within the ZEUS System, when used with the Zio Watch, demonstrated an interval-level sensitivity of 93.6% and specificity of 99.1% for AFib detection in a Verily study. The PPG-derived AFib burden estimate from the Zio Watch was found to be accurate when compared to the Zio XT reference.
Cardiac Monitoring Integration
The ZEUS System is an integral part of the Zio Service, which combines Zio monitoring devices (e.g., Zio monitor, Zio Watch) with the ZEUS software for comprehensive cardiac data analysis. The Zio monitor offers continuous, single-channel ECG recording for up to 14 days. The Zio Watch is a wrist-worn wearable designed for long-term continuous monitoring, particularly for Atrial Fibrillation. The ZioSuite software module, part of the ZEUS System, facilitates patient registration, access to clinical reports, and management of report interpretation.
Physician Tip

The ZEUS System provides preliminary, end-of-wear reports that serve as an aid in arrhythmia diagnosis and management; final diagnosis should be based on the physician's clinical judgment, experience, and the patient's medical history. It is crucial to ensure accurate and complete patient registration to prevent misdiagnosis or limited functionality. The system is not intended for critical care patients or situations demanding real-time monitoring. Physicians should be aware that QT interval measurements from the ZEUS System may underestimate global QT measurements from a 12-lead ECG. Utilizing the ZioSuite web portal and mobile application can streamline clinical workflows.

The Zio service, including the ZEUS System, offers direct integration with Electronic Health Record (EHR) systems, such as Epic Aura, to streamline cardiac monitoring workflows. This integration enables ordering and registering Zio ECG monitors directly through the EHR and facilitates electronic delivery of Zio reports back into the EHR. Physicians can interpret these reports from their EHR, CVIS, or ZioSuite. The ZEUS System was developed in partnership with Verily, an Alphabet company, and the Zio Watch with ZEUS System is designed as an integrated, prescription-based solution to enhance clinician workflows and patient experience. The system ensures data security with encryption in motion and at rest (HTTPS, AES-256), role-based access controls, and is cloud-based on the AWS EC2 platform with HL7-based EHR integration.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing — Not publicly available
DeploymentCloud-based (AWS EC2 platform)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The Zio ECG Utilization Software (ZEUS) System received FDA 510(k) clearance (K202527) on May 21, 2021. Subsequent clearances include K222389 for the ZEUS System on February 15, 2023, and 510(k) clearance for the Zio Watch with ZEUS System in July 2022 for AFib detection.

Integrations
EHR Not specified
Specialties Cardiology, Family Medicine, Internal Medicine

What the Web Says

The Zio ECG Utilization Software (ZEUS) System, developed by iRhythm, is generally well-regarded for its integration with Zio monitors, aiming to streamline ECG data management and analysis for physicians. Reviews highlight its potential to improve workflow efficiency and provide actionable insights from cardiac monitoring data.

Overall: Positive

Strengths

  • Seamless integration with Zio XT and AT monitors.
  • Streamlined workflow for ECG data management and review.
  • Provides comprehensive and actionable insights from cardiac data.
  • User-friendly interface for physicians.
  • Reduces manual data handling and potential for errors.
  • Supports efficient diagnosis and treatment planning.

Limitations

  • Learning curve for new users.
  • Dependency on the iRhythm ecosystem (Zio monitors).
  • Potential for integration challenges with existing EMR systems.
  • Cost of implementation and ongoing subscriptions.
  • Some users report occasional software glitches or slowness.
  • Limited customization options for specific clinical workflows.

Based on reviews from: iRhythm Technologies official website, Physician forums and discussions, Healthcare IT reviews, Medical technology publications, Reddit discussions (r/medicine, r/healthcareit), G2 reviews, Capterra reviews

Last updated: 2026-07-18

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Press & Coverage

iRhythm Technologies
iRhythm Gains FDA Clearance for its Clinically Integrated ZEUS System
iRhythm Technologies received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch, developed in partnership with Verily. The system uses deep-learned algorithms for long-term continuous monitoring of atrial fibrillation (AFib).
2022-07
Cardiac Rhythm News
iRhythm's ZEUS system gains US FDA approval - Cardiac Rhythm News
iRhythm Technologies secured FDA 510(k) clearance for its ZEUS system for the Zio Watch, an AI-powered wearable for non-invasive, long-term continuous monitoring of atrial fibrillation. The system is a result of a partnership with Verily.
2022-07
NS Medical Devices
iRhythm secures CE Mark approval for Zio monitor and ZEUS System - NS Medical Devices
iRhythm Technologies received CE mark certification under the EU MDR for its Zio monitor ECG system and the integrated ZEUS (Zio ECG Utilization Software) system, an advanced deep-learned AI algorithm for cardiac arrhythmia detection.
2024-01
GlobeNewswire
iRhythm Technologies Receives European Union's CE Marking Under Medical Device Regulation (EU MDR) for its Ziou00ae monitor and ZEUS System
iRhythm Technologies announced that its Zio monitor ECG System and the ZEUS (Zio ECG Utilization Software) System received CE mark certification under the European Union's Medical Device Regulation. This certification allows for market expansion in Europe.
2024-01
Bionics Gamechangers
Zio ECG Monitor and ZEUS AI System Receive CE Marking | Bionics Gamechangers
iRhythm Technologies obtained CE marking for its Zio monitor system, supported by the ZEUS deep-learned AI algorithm, for detecting cardiac arrhythmias. This approval facilitates market expansion in Europe.
2024-01
Nasdaq
iRhythm Technologies Expands Global Reach with the Launch of Ziou00ae Cardiac Arrhythmia Monitoring Service in Austria, the Netherlands, Switzerland, and Spain | Nasdaq
iRhythm Technologies commercially launched its Zio monitor and Zio long-term continuous ambulatory ECG monitoring service in Austria, the Netherlands, Spain, and Switzerland, following the Zio monitor and ZEUS system receiving EU MDR CE Marking in December 2023.
2024-08
Nasdaq
iRhythm Technologies Announces Japanese Regulatory Approval of the Ziou00ae ECG Monitoring System, the First Product to Deliver Arrhythmia Monitoring Service Utilizing Artificial Intelligence
iRhythm Technologies received regulatory approval from the Japanese PMDA for the Zio fourteen-day, long-term continuous ECG monitoring system, which includes the ZEUS (Zio ECG Utilization Software) System.
2024-09
Current Medical Research and Opinion
Cardiac arrhythmia detection outcomes among patients monitored with the Zio patch system: a systematic literature review
This peer-reviewed article discusses how iRhythm's Zio ECG Utilization Service (ZEUS) processes and analyzes ECG data from the Zio cardiac arrhythmia recording system, leading to improved patient wear times and higher arrhythmia detection rates.
2019-05

Videos

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Frequently Asked Questions

The ZEUS system utilizes proprietary, deep-learned AI algorithms to analyze ECG data collected from Zio monitors, generating preliminary findings. These AI-analyzed results are then reviewed and verified by Certified Cardiographic Technicians (CCTs) before a comprehensive report is made available to you via the ZioSuite web portal or mobile app. This process aims to streamline your workflow by providing actionable, pre-analyzed data to aid in your final diagnosis.
The ZEUS system's advanced AI technology is FDA-cleared in the United States and holds the CE marking CE-2797, demonstrating conformity with the EU Medical Device Regulation (MDR) 2017/745. It also has approvals in other regions like the UK and Japan. iRhythm has actively addressed and received 510(k) clearance for design modifications to ensure ongoing regulatory compliance.
The Zio system, with its AI-driven analysis, is associated with a higher diagnostic yield and a lower likelihood of retesting for specified arrhythmias compared to traditional Holter monitoring services. Its deep-learned algorithm is clinically proven to classify a broad range of arrhythmias with high diagnostic performance, similar to that of cardiologists, and boasts a 99% physician agreement rate with its end-of-wear reports.
The Zio monitor service is typically billed under CPT codes 93243 (for 48 hours to 7 days) and 93247 (for 7 to 15 days), with iRhythm managing the technical component's insurance claims. Physicians can bill separately for on-site application and final interpretation of the results. Medicare covers the Zio system nationwide, and most major commercial insurance plans also provide coverage, though patient out-of-pocket costs may vary based on their specific plan benefits.
The ZEUS system is not intended for use in critical care patients or those with symptomatic episodes where variations in cardiac performance could result in immediate danger. Additionally, Zio monitors are contraindicated in MRI environments, during external cardiac defibrillation, or with high-frequency surgical equipment, and may be affected by neuro-stimulators. Physicians should also note that ZEUS System QT interval measurements might underestimate global QT measurements from a 12-lead ECG.
The ZEUS system's AI utilizes deep-learned algorithms to process ECG data and detect arrhythmias, demonstrating high diagnostic performance. However, the AI-generated preliminary findings are always curated and verified by Qualified Cardiac Technicians (CCTs) before a final report is issued. This combination of advanced AI and expert human review ensures a high level of accuracy and clinical confidence, with 99% physician agreement on the end-of-wear reports.
Patient data processed by the ZEUS system is handled through secure channels, including a secure website for physicians to access reports. iRhythm is committed to complying with all applicable laws regarding the transmission of protected health information, including clinical and personal data. The system is designed with regulatory compliance in mind, including adherence to medical device regulations that mandate data security and privacy protocols.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

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