Zio by iRhythm logo

Zio by iRhythm

by iRhythm Technologiesirhythmtech.com
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OVERVIEW

A leadless, long-term continuous ECG monitoring service and wearable patch for diagnosing cardiac arrhythmias, powered by FDA-cleared AI analysis.

Zio by iRhythm is an end-to-end ambulatory cardiac monitoring service designed to diagnose cardiac arrhythmias, such as Atrial Fibrillation, Tachycardia, and Bradycardia, over an extended period. The service centers around the Zio ECG monitor (a small, water-resistant, leadless patch) which is worn for up to 14 days, providing continuous, uninterrupted ECG recording.

The core of the service's software component is the Zio ECG Utilization Software (ZEUS) System, which employs an advanced, FDA-cleared, deep-learned AI algorithm to process and analyze the millions of heartbeats recorded. The data is then curated and verified by Qualified Cardiac Technicians (QCTs) to generate a comprehensive end-of-wear report for the prescribing physician. The final reports have demonstrated 99% physician agreement.

For clinicians, the service provides the ZioSuite web portal and mobile app, which streamlines clinical workflows, enabling remote patient registration, device tracking, report interpretation, and patient management. Patients are supported by the MyZio mobile app, which allows for digital symptom logging, educational content, and reminders, contributing to high patient compliance.

The Zio service is associated with a higher diagnostic yield and a lower likelihood of retesting compared to traditional 24-48 hour Holter monitoring, making it a highly effective tool for detecting infrequent or sporadic arrhythmias.

RATING & STATS

Customers
10,000,000+
Founded
2006

KEY FEATURES

  • Continuous ECG Monitoring (up to 14 days)
  • Leadless/Wire-free Patch Design (Zio monitor/XT/AT)
  • FDA-cleared AI Analysis (ZEUS System)
  • Comprehensive End-of-Wear Report (99% physician agreement)
  • MyZio Patient App (Digital Symptom Logging)
  • ZioSuite Provider Portal & Mobile App
  • EHR Integration
  • Patient-Triggered Event Recording

PRICING

Model: enterprise
The Zio service is prescription-only and operates on a medical reimbursement model. iRhythm uses a Direct Bill Program to invoice the patient's insurance (Medicare or commercial payer) for the technical component. Patient costs are based on individual insurance plans (co-pay, deductible, co-insurance). Financial assistance and self-pay options at a discounted rate are available. Pricing is not publicly disclosed.

TECHNICAL DETAILS

Deployment: saas, cloud
Platforms: web, ios, android
📱 Mobile Apps🔌 API Available

USE CASES

Diagnosis of Cardiac Arrhythmias (e.g., Atrial Fibrillation, Tachycardia)Long-term Continuous ECG MonitoringMonitoring treatment effectivenessCardio-Kidney-Metabolic (CKM) risk assessment

INTEGRATIONS

EHR Integration

COMPLIANCE & SECURITY

Compliance:
FDA 510(k) clearedCE markedUKCA markedHIPAASOC2 Type IIGDPR
Security Features:
  • 🔒FIPS 140-2 Validation (Data Encryption)

SUPPORT & IMPLEMENTATION

Support: email, phone, 24/7 support
Implementation Time: 1-4 weeks
Target Company Size: medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Superior diagnostic yield for long-term monitoring (up to 14 days) over Holter monitors.
  • +High patient compliance (99%) due to comfortable, leadless, and water-resistant patch.
  • +AI-powered analysis (ZEUS) verified by QCTs for high accuracy and actionable reports.
  • +End-to-end service reduces administrative burden on the provider's office.
✗ Cons:
  • -Single-lead recording may limit detailed analysis of complex arrhythmias compared to multi-lead devices.
  • -Prescription-only service model is tied to complex medical reimbursement and insurance rates.
  • -Patient application process requires skin prep (shaving/abrasion) which can cause minor discomfort.

ABOUT IRHYTHM TECHNOLOGIES