{"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"}}