Zio Monitor

JSON twin: https://www.healthaidb.com/software/zio-monitor.json

Company Name

iRhythm Technologies

Product URL

https://www.irhythmtech.com/us/en/solutions-services/irhythm-service/zio-monitor

Company URL

https://www.irhythmtech.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

Zio Monitor by iRhythm Technologies is a lightweight, comfortable, and accurate long-term continuous cardiac monitoring device that ensures high patient compliance and delivers comprehensive ECG data for up to 14 days.

Description

Zio Monitor is a prescription-only, single-use ambulatory ECG monitor designed for continuous, uninterrupted recording of ECG data for up to 14 days. It features a breathable, pliable, and waterproof housing, making it suitable for daily activities such as sleeping, showering, and exercising. The device is part of iRhythm's Zio long-term continuous monitoring service, which includes the ZEUS (Zio ECG Utilization Software) system and comprehensive end-of-wear reports reviewed by certified cardiographic technicians. The service boasts a 99% physician agreement rate on its reports and is associated with the highest diagnostic yield of specified arrhythmias compared to other monitoring services. Zio Monitor is CE-marked and available in the United States, United Kingdom, Japan, Austria, the Netherlands, Spain, and Switzerland.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 27001

Company Founding

2006

Company Offices

• United States
• United Kingdom
• Japan
• Austria
• Netherlands
• Spain
• Switzerland

Compliance

• HIPAA
• SOC 2 Type II
• FIPS 140-2
• GDPR
• CCPA
• EU-U.S. Data Privacy Framework
• UK Extension to the EU-U.S. Data Privacy Framework

Customers

• Montefiore Health System
• iRhythm Technologies

Data Residency

U.S. and EU regions

Data Standards

• HL7 v2 (v2.3+)
• HTTPS/SFTP secure transport

Deployment Model

• SaaS

Features

• Continuous, uninterrupted ECG recording
• Comprehensive end-of-wear reports
• High patient compliance (99%)
• Patient-centric design for ease of use
• Breathable, pliable, and waterproof housing
• FDA-cleared AI algorithm for data analysis
• ZioSuite provider portal for case/report management
• MyZio patient mobile app for engagement
• Discrete data delivery to EHRs
• Automatic electronic delivery of reports to EHRs
• Integration with Epic's Aura platform
• Integration with Cerner, Athenahealth, Meditech, eClinicalWorks, and 350+ ambulatory EHR systems via HL7/Aura
• Support for value-based care workflows
• Device management of Zio ECG monitors
• Clinical workflow automation and registration elimination
• Dedicated integration project management and go-live support
• Reporting and analytics for population health

Id

SW0385

Integration Partners

• Cerner
• Allscripts
• Epic Systems
• Medtronic
• Philips Healthcare
• GE Healthcare
• Siemens Healthineers
• IBM Watson Health
• Oracle Health Sciences
• McKesson Corporation
• Medtronic Care Management Services
• GE Healthcare IT
• Philips IntelliSpace
• Siemens Healthineers Syngo
• IBM Watson Health Imaging
• Oracle Health Sciences Cloud
• McKesson Paragon
• Medtronic CareLink
• GE Healthcare Centricity
• Philips IntelliVue

Integrations

• Epic (Aura)
• Cerner
• Athenahealth
• Meditech
• eClinicalWorks
• 350+ ambulatory EHR systems via HL7/Aura

Languages Supported

• English
• Japanese
• German
• Dutch
• Spanish

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB
• Consumer

Optional Modules

• ZioSuite
• MyZio app

Os Platforms

• Web
• iOS
• Android

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent management
• Data anonymization
• Data minimization

Product Code

SW0385

Product Name

Zio Monitor

Ratings

• 4.4/5 (37 reviews) - G2
• 3.9/5 (41 reviews) - G2
• 3.9/5 (72 reviews) - G2
• 3.9/5 (12 reviews) - G2
• 3.9/5 (14 reviews) - G2
• 3.9/5 (176 reviews) - G2

Regions Available

• United States
• United Kingdom
• Japan
• Austria
• Netherlands
• Spain
• Switzerland

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2011

Security Features

• Encryption (HTTPS, AES-256)
• Role-based access controls
• Single Sign-On (SSO) via SAML
• Enforced Multi-Factor Authentication (MFA)
• Audit logs
• 24-hour monitoring
• Regular penetration and vulnerability testing

Specialties

• Cardiology
• Electrophysiology

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Target Users

• Clinicians
• Patients
• Admins

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• The unhelpful support staff and the inability of providing the help that we needed to get our clinic set up are two MAJOR reasons why I would never recommend this company.
• We do not like anything about this company.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Zio Monitor",
  "company_name": "iRhythm Technologies",
  "product_url": "https://www.irhythmtech.com/us/en/solutions-services/irhythm-service/zio-monitor",
  "company_url": "https://www.irhythmtech.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0385",
  "summary": "Zio Monitor by iRhythm Technologies is a lightweight, comfortable, and accurate long-term continuous cardiac monitoring device that ensures high patient compliance and delivers comprehensive ECG data for up to 14 days.",
  "description": "Zio Monitor is a prescription-only, single-use ambulatory ECG monitor designed for continuous, uninterrupted recording of ECG data for up to 14 days. It features a breathable, pliable, and waterproof housing, making it suitable for daily activities such as sleeping, showering, and exercising. The device is part of iRhythm's Zio long-term continuous monitoring service, which includes the ZEUS (Zio ECG Utilization Software) system and comprehensive end-of-wear reports reviewed by certified cardiographic technicians. The service boasts a 99% physician agreement rate on its reports and is associated with the highest diagnostic yield of specified arrhythmias compared to other monitoring services. Zio Monitor is CE-marked and available in the United States, United Kingdom, Japan, Austria, the Netherlands, Spain, and Switzerland.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB",
    "Consumer"
  ],
  "target_users": [
    "Clinicians",
    "Patients",
    "Admins"
  ],
  "specialties": [
    "Cardiology",
    "Electrophysiology"
  ],
  "regions_available": [
    "United States",
    "United Kingdom",
    "Japan",
    "Austria",
    "Netherlands",
    "Spain",
    "Switzerland"
  ],
  "languages_supported": [
    "English",
    "Japanese",
    "German",
    "Dutch",
    "Spanish"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "United Kingdom",
    "Japan",
    "Austria",
    "Netherlands",
    "Spain",
    "Switzerland"
  ],
  "company_founding": "2006",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android"
  ],
  "features": [
    "Continuous, uninterrupted ECG recording",
    "Comprehensive end-of-wear reports",
    "High patient compliance (99%)",
    "Patient-centric design for ease of use",
    "Breathable, pliable, and waterproof housing",
    "FDA-cleared AI algorithm for data analysis",
    "ZioSuite provider portal for case/report management",
    "MyZio patient mobile app for engagement",
    "Discrete data delivery to EHRs",
    "Automatic electronic delivery of reports to EHRs",
    "Integration with Epic's Aura platform",
    "Integration with Cerner, Athenahealth, Meditech, eClinicalWorks, and 350+ ambulatory EHR systems via HL7/Aura",
    "Support for value-based care workflows",
    "Device management of Zio ECG monitors",
    "Clinical workflow automation and registration elimination",
    "Dedicated integration project management and go-live support",
    "Reporting and analytics for population health"
  ],
  "optional_modules": [
    "ZioSuite",
    "MyZio app"
  ],
  "integrations": [
    "Epic (Aura)",
    "Cerner",
    "Athenahealth",
    "Meditech",
    "eClinicalWorks",
    "350+ ambulatory EHR systems via HL7/Aura"
  ],
  "data_standards": [
    "HL7 v2 (v2.3+)",
    "HTTPS/SFTP secure transport"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "SOC 2 Type II",
    "FIPS 140-2",
    "GDPR",
    "CCPA",
    "EU-U.S. Data Privacy Framework",
    "UK Extension to the EU-U.S. Data Privacy Framework"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 27001"
  ],
  "security_features": [
    "Encryption (HTTPS, AES-256)",
    "Role-based access controls",
    "Single Sign-On (SSO) via SAML",
    "Enforced Multi-Factor Authentication (MFA)",
    "Audit logs",
    "24-hour monitoring",
    "Regular penetration and vulnerability testing"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent management",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "U.S. and EU regions",
  "customers": [
    "Montefiore Health System",
    "iRhythm Technologies"
  ],
  "user_reviews": [
    "The unhelpful support staff and the inability of providing the help that we needed to get our clinic set up are two MAJOR reasons why I would never recommend this company.",
    "We do not like anything about this company."
  ],
  "ratings": [
    "4.4/5 (37 reviews) - G2",
    "3.9/5 (41 reviews) - G2",
    "3.9/5 (72 reviews) - G2",
    "3.9/5 (12 reviews) - G2",
    "3.9/5 (14 reviews) - G2",
    "3.9/5 (176 reviews) - G2"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2011",
  "integration_partners": [
    "Cerner",
    "Allscripts",
    "Epic Systems",
    "Medtronic",
    "Philips Healthcare",
    "GE Healthcare",
    "Siemens Healthineers",
    "IBM Watson Health",
    "Oracle Health Sciences",
    "McKesson Corporation",
    "Medtronic Care Management Services",
    "GE Healthcare IT",
    "Philips IntelliSpace",
    "Siemens Healthineers Syngo",
    "IBM Watson Health Imaging",
    "Oracle Health Sciences Cloud",
    "McKesson Paragon",
    "Medtronic CareLink",
    "GE Healthcare Centricity",
    "Philips IntelliVue"
  ],
  "id": "SW0385",
  "slug": "zio-monitor",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/zio-monitor.json"
  }
}