Zio XT ECG Monitoring System
Overview
The Zio XT ECG Monitoring System, developed by iRhythm Technologies, is a remote cardiac monitoring service designed to detect cardiac arrhythmias. It comprises three main components: the Zio biosensor, a wearable single-lead ambulatory electrocardiogram (ECG) patch; ZEUS, a proprietary, regulated software platform and online portal that stores, analyzes, and sorts ECG data; and a Zio technical report, which provides a clinically actionable summary of the recorded ECG data. The Zio XT biosensor is a single-patient-use, water-resistant device that records continuous beat-to-beat ECG for up to 14 days, offering a longer monitoring period than traditional Holter monitors. Patients can wear the device during daily activities, including showering or bathing, with minimal disruption, contributing to high patient compliance (up to 98-99%). The system utilizes an advanced, FDA-cleared, deep-learned AI algorithm to process recorded ECG data, which is then curated and verified by Qualified Cardiac Technicians to generate comprehensive end-of-wear reports with high physician agreement. This end-to-end solution aims to provide accurate, clinically actionable data to healthcare professionals, facilitating timely diagnosis and management of cardiac conditions.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Wearable single-lead ECG biosensor (Zio biosensor)
- Continuous ambulatory cardiac monitoring for up to 14 days
- Water-resistant design for normal daily activities, including showering
- No external leads or wires for enhanced patient comfort and reduced artifacts
- Proprietary, FDA-cleared deep-learned AI algorithm for ECG data analysis
- Cloud-based software platform (ZEUS) for data storage, analysis, and reporting
- Patient-activated button for symptomatic event logging
- High patient compliance (up to 99%) and satisfaction
- Comprehensive end-of-wear reports with high physician agreement (99%)
- HL7-based EHR integration
Use Cases
- Detection of cardiac arrhythmias
- Evaluation of transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety
- Screening for atrial fibrillation (AFib)
- Monitoring patients after transcatheter aortic valve replacement (TAVR)
- Replacing or enhancing standard care (e.g., Holter monitoring) for arrhythmia detection
- Reducing hospital stays for patients with suspected cardiac events
What Physicians Need to Know
For patients with suspected cardiac arrhythmias, especially those with transient or infrequent symptoms, Zio XT's extended monitoring period (up to 14 days) significantly increases the likelihood of capturing elusive events compared to shorter-term monitors. Encourage patients to utilize the symptom-press button for accurate symptom-rhythm correlation. Be mindful that Zio XT is a post-monitoring diagnostic tool and does not offer real-time alerts; therefore, it is contraindicated for patients requiring immediate cardiac intervention or continuous real-time telemetry. Leverage EHR integrations, particularly with Epic via Aura, and the ZioSuite portal to streamline ordering, patient enrollment (including home enrollment), and efficient review of comprehensive reports.
The Zio XT system offers comprehensive integration capabilities, notably with Electronic Health Record (EHR) systems like Epic through the Aura network. This integration facilitates seamless electronic ordering, patient registration, and the direct delivery of Zio end-of-wear reports into the patient's record. The ZioSuite web portal and mobile app further enhance workflow efficiency by enabling remote patient management and report access. While reports are delivered electronically, it's important to note that daily reports are available in ZioSuite, and physician-interpreted reports are subsequently posted to the EHR, rather than real-time transmission of raw data or alerts.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing |
Contact for pricing
|
| Deployment | Cloud-based (AWS EC2 platform), no on-premise hardware required. |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated The Zio XT ECG Monitoring System is 510(k) cleared by the FDA. The K number associated with the Zio XT Patch is K121319. The Zio ECG Utilization Software (ZEUS), which includes the deep-learned AI algorithm, is also 510(k) cleared. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Emergency Medicine, Internal Medicine |
What the Web Says
The Zio XT ECG Monitoring System is a wearable, adhesive patch designed for continuous heart rhythm monitoring for up to 14 days, offering a longer monitoring period than traditional Holter monitors. It utilizes AI-based algorithms and certified cardiographic technicians for data analysis, providing comprehensive reports to physicians. While generally considered easy to use and more comfortable than Holter monitors, some users report significant skin irritation and discomfort from the adhesive and application process. Studies suggest Zio XT has a higher diagnostic yield and faster time to diagnosis for various arrhythmias compared to other ambulatory cardiac monitors.
Overall: MixedStrengths
- Longer continuous monitoring period (up to 14 days) compared to traditional Holter monitors.
- Higher diagnostic yield and faster time to diagnosis for cardiac arrhythmias.
- More comfortable and discreet than traditional Holter monitors due to its patch design and lack of wires.
- Water-resistant, allowing patients to shower or bathe while wearing it.
- Utilizes AI-based algorithms and certified technicians for efficient data analysis and comprehensive reports.
- Can be self-applied and mailed back, reducing the need for in-person clinic visits for fitting and follow-up.
Limitations
- Significant skin irritation, itching, and rashes reported by many users due to the adhesive and skin preparation (shaving, sandpaper, alcohol).
- Application process can be painful and uncomfortable.
- Some users report the device falling off prematurely or having issues with adhesive loosening.
- Does not provide real-time feedback or alerts to the patient.
- Can be expensive, with some users reporting high out-of-network costs.
- Lack of long-term impact data and, in some analyses, not found to be cost-saving compared to current practice.
Based on reviews from: iRhythm, Reddit, YouTube, NICE, PMC, Oxford Academic, Diagnostic and Interventional Cardiology, NHS Health Research Authority, RhythmScience, Medical Device Network, Bardy Diagnostics, MaineHealth Knowledge Connection, accessdata.fda.gov
Last updated: 2026-07-19
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate Zio XT ECG Monitoring System
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for Zio XT ECG Monitoring System.
Zio Cardiac Monitor Introduction
No FAQs available yet for this tool.
Compare Zio XT ECG Monitoring System
VS
VS
VS
VS
Investors who backed Zio XT ECG Monitoring System
Funded through the company that built this tool.
