Zio AT ECG Monitoring System

by iRhythm Technologies, Inc.  · Based in United States → — Shaping the future of heart monitoring and empowering better health for all.
Cardiology

Contact for pricing
Regulatory Status Disclosed

Overview

The Zio AT ECG Monitoring System, developed by iRhythm Technologies, Inc., is a comprehensive ambulatory mobile cardiac telemetry (MCT) service designed for continuous, long-term monitoring of a patient’s electrocardiogram (ECG) data. It aims to simplify cardiac monitoring by providing uninterrupted recording and timely arrhythmia detection. The system consists of a Zio AT patch ECG monitor, a wireless gateway for data transmission, and the Zio ECG Utilization Software (ZEUS) which incorporates a deep-learned, FDA-cleared AI algorithm for analysis and reporting.

The Zio AT patch is a single-use, flexible, lightweight, and water-resistant device that can be worn for up to 14 days during routine activities, including showering and sleeping, without requiring battery changes or charging. It captures both patient-triggered and automatically detected symptomatic and asymptomatic cardiac events. Data is transmitted wirelessly to a monitoring center, and comprehensive end-of-wear reports are generated for clinicians, with a high rate of physician agreement.

The system is supported by the ZioSuite® clinician portal and a provider mobile app for report interpretation and patient management, as well as the MyZio® patient app for symptom logging and educational content. iRhythm Technologies emphasizes robust data security, privacy practices, and compliance with industry standards, including HIPAA, SOC 2 Type II certification, and GDPR.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Wearable Zio AT patch for continuous ECG recording
  • Wireless gateway for real-time data transmission
  • FDA-cleared deep-learned AI algorithm (ZEUS System) for arrhythmia detection
  • Continuous, uninterrupted ECG recording for up to 14 days
  • Detection of symptomatic and asymptomatic cardiac events
  • Comprehensive end-of-wear reports for clinicians
  • ZioSuiteu00ae clinician portal and mobile app for patient management and report interpretation
  • MyZiou00ae patient mobile app for symptom logging and education
  • Water-resistant and lightweight patient-centered design
  • No battery changes or charging required during wear

Use Cases

  • Detection and diagnosis of irregular heart rhythms, including atrial fibrillation (AF)
  • Long-term ambulatory cardiac monitoring for transient symptoms (palpitations, dizziness, syncope)
  • Monitoring patients post-stroke or TIA to identify underlying cardiac arrhythmias
  • Post-procedure monitoring, such as after transcatheter aortic valve replacement (TAVR)
  • Reducing hospital stays for patients presenting with syncope
  • Providing actionable heartbeat data for clinical decision-making

What Physicians Need to Know

ECG/EKG Analysis Capability
The Zio AT system provides continuous, uninterrupted ECG recording for up to 14 days. It utilizes an FDA-cleared, deep-learned AI algorithm, combined with review by Qualified Cardiac Technicians, to analyze ECG data and generate comprehensive end-of-wear reports with 99% physician agreement. The system can classify a broad range of arrhythmias with diagnostic performance comparable to cardiologists and detects 13 different types of arrhythmias, along with sinus rhythm and artifacts. Proprietary hydrogel electrodes are designed to ensure an ECG signal with minimal artifact.
Arrhythmia Detection Accuracy
The advanced AI algorithm is FDA-cleared and clinically proven to be as accurate as cardiologists for arrhythmia detection. Studies indicate that long-term, continuous monitoring with Zio AT leads to higher cardiac arrhythmia detection rates compared to short-duration monitoring (e.g., 24-48 hour Holter monitors), particularly for paroxysmal atrial fibrillation. The system boasts 99% analyzable time, supported by high patient compliance (98%).
Heart Failure Risk Prediction
Research suggests that incorporating ECG data from long-term continuous monitoring, such as that provided by Zio, can more accurately predict heart failure hospitalization compared to clinical history or risk scores alone, with arrhythmias like Afib and ventricular ectopy being highly associated with new-onset heart failure. However, it is important to note that Zio Long-Term Continuous Monitors (LTCMs) are not FDA-cleared to predict disease states.
Cardiac Monitoring Integration
The Zio AT system offers robust EHR integration, including seamless connectivity with Epic via the Aura network, to streamline ordering and reporting workflows. Healthcare providers can submit and sign electronic orders and interpret/sign end-of-wear reports directly within their EHR environment. The ZioSuite portal and provider mobile app facilitate report interpretation and patient management, while the MyZio patient app supports digital symptom logging, educational content, and reminders for patients.
AHA/ACC Guideline Alignment
The Zio AT system aligns with AHA/ACC/HRS recommendations for ECG documentation to diagnose atrial fibrillation, particularly the need for prolonged or frequent monitoring to detect asymptomatic episodes. NICE guidelines also support ambulatory ECG monitoring when a 12-lead ECG is non-diagnostic and paroxysmal atrial fibrillation is suspected, with Zio AT intended to enhance or replace standard short-term monitoring. The value of the iRhythm service is supported by over 100 original scientific research manuscripts.
Real-Time Alert Capability
Zio AT functions as a mobile cardiac telemetry (MCT) service, providing wear-time transmissions of symptomatic and asymptomatic cardiac events through a wireless gateway. In a syncope study, arrhythmias triggering alerts were detected in 8.2% of patients, with an average notification time of 89 hours. However, the system is contraindicated for critical care patients or those with symptomatic episodes posing immediate danger, as its reporting timeliness is not consistent with life-threatening arrhythmias like ventricular fibrillation. The system has transmission limits for events, and while recording continues, notifications of actionable arrhythmias may be delayed if limits are reached.
Physician Tip

Leverage the Zio AT's extended, continuous monitoring capabilities for a higher diagnostic yield, especially for infrequent or asymptomatic arrhythmias that might be missed by shorter-term monitors. Utilize the AI-powered analysis and technician review for efficient and accurate reports, and integrate the system with your EHR for streamlined workflows and patient management. While effective for mobile cardiac telemetry, be mindful of its contraindications for critical care patients or situations requiring immediate real-time intervention for life-threatening arrhythmias. Encourage patients to actively use the MyZio app for symptom logging to enhance the correlation between symptoms and detected rhythms.

The Zio AT ECG Monitoring System offers comprehensive integration capabilities designed to enhance clinical workflow efficiency. It integrates directly with Electronic Health Record (EHR) systems, including Epic via the Aura network, enabling seamless electronic ordering, secure transmission of results, and direct interpretation of Zio reports within the EHR environment. This HL7-compatible integration simplifies data collection, reduces errors, and improves interdisciplinary access to patient cardiac data. Additionally, the MyZio patient app provides a direct channel for patient engagement, allowing for digital symptom logging and access to educational content, further integrating the patient's experience into the overall monitoring process.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing — Not publicly disclosed; typically involves service fees for monitoring and analysis.
DeploymentCloud-based (data analytics and clinician portal)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Zio AT ECG Monitoring System, including its ZEUS System (software/algorithm component), has received multiple FDA 510(k) clearances. K181502, cleared on August 29, 2018, specifically pertains to an update of the ZEUS System's rhythm classification algorithm to a deep-learning basis. The device is a prescription-only outpatient cardiac telemetry device.

Integrations
EHR Not specified
Specialties Cardiology

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Press & Coverage

iRhythm Technologies, Inc. (Press Release)
iRhythm Holdings Announces First Quarter 2026 Financial Results
iRhythm Holdings, Inc. reported strong financial results for the first quarter of 2026, with revenue increasing by 25.7% year-over-year, driven by increased volume of Zio Services.
2026-04
MedTech Dive
IRhythm discloses data stolen from third-party applications in cyberattack
iRhythm disclosed a cyberattack in June 2026 where data, including proprietary and patient protected health information, was stolen from third-party-hosted business applications.
2026-06
MarketScreener (Globe Newswire)
New Data Presented at HRS 2026 Show Short-Term Holter Monitoring Misses a Large Proportion of AF Recurrence Post-Ablation and Clinically Significant Arrhythmias in Pregnancy
New data presented at HRS 2026 highlighted that short-term Holter monitoring is less effective than iRhythm's Zio ambulatory ECG devices in detecting AF recurrence post-ablation and clinically significant arrhythmias in pregnant patients.
2026-04
iRhythm Technologies, Inc. (Press Release)
iRhythm Holdings to Report Second Quarter 2026 Financial Results on August 6, 2026
iRhythm Holdings announced it will report its second quarter 2026 financial results on August 6, 2026.
2026-07
iRhythm Technologies, Inc. (Press Release)
iRhythm Technologies, Inc. Shares Preliminary Fourth Quarter 2025 Highlights and Business Update at the 44th Annual J.P. Morgan Healthcare Conference
iRhythm Technologies provided preliminary fourth quarter 2025 operational highlights and a business update at the J.P. Morgan Healthcare Conference, anticipating full-year 2025 revenue to exceed guidance.
2026-01
MarketBeat
Allspring Global Investments Holdings LLC Acquires 59,704 Shares of iRhythm Technologies $IRTC
Allspring Global Investments Holdings LLC increased its stake in iRhythm Technologies by 14.7% in the first quarter of 2026, following iRhythm's better-than-expected quarterly results.
2026-07
FDA
Zio AT ECG Monitoring System FDA 510(k) Clearance
The Zio AT ECG Monitoring System received FDA 510(k) clearance, intended for continuous, long-term monitoring of ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias.
2024-10
ResearchGate
Digital Health Trends 2024 Report
The Zio AT ECG Monitoring System is listed among various digital health products and systems in a report examining trends across the digital health market in 2024.
2024-12

Videos

Product demos, reviews, and walkthroughs for Zio AT ECG Monitoring System.

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Frequently Asked Questions

The Zio AT system utilizes a deep-learned, FDA-cleared AI algorithm, known as Zio ECG Utilization Software (ZEUS), to analyze continuous ECG data for cardiac events. While the AI provides initial analysis, qualified cardiac technicians review and validate the findings, generating comprehensive reports for the physician's final clinical decision. This combined approach aims to enhance diagnostic accuracy and efficiency.
The Zio AT system has received FDA 510(k) clearance for its device and updated AI capabilities, indicating it is substantially equivalent to legally marketed predicate devices. iRhythm, the manufacturer, is committed to complying with HIPAA and GDPR regulations, undergoing regular independent third-party assessments and maintaining SOC 2 Type II certification for data security and privacy.
The Zio AT offers continuous ECG monitoring for up to 14 days, providing a longer diagnostic window than traditional 24-48 hour Holter monitors and often leading to higher diagnostic yields. Its advanced AI algorithm, combined with expert human review, is clinically proven to be as accurate as cardiologists in detecting and classifying arrhythmias, distinguishing it from some consumer-grade wearables.
The Zio AT system has transmission limits, specifically 100 patient-triggered and 500 automatically detected arrhythmia events, after which real-time data transmission for immediate review ceases, though the device continues to record for the final report. It is also contraindicated for critical care patients and should not be used when real-time or in-patient monitoring is required.
The Zio monitoring service is covered by many major commercial insurance plans and Medicare. iRhythm handles the technical component billing (CPT codes 93243 for 48 hours to 7 days, or 93247 for 7 to 15 days), while physicians can bill for the application and interpretation services. Patient assistance programs are also available to help manage potential out-of-pocket expenses.
iRhythm is dedicated to maintaining the privacy and security of Protected Health Information (PHI) by adhering to HIPAA and GDPR requirements. Patient data is encrypted both in transit and at rest, and the company holds SOC 2 Type II certification and FIPS 140-2 validation for its data encryption practices.
Yes, the Zio AT system offers EHR integration services, including a collaboration with Epic via its Aura network, to streamline workflows. This integration allows for direct ordering of Zio monitors and electronic delivery of comprehensive end-of-wear reports into the patient's EHR, aiming to improve operational efficiency and reduce staff workload.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19

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