FDA-Cleared AI Algorithm
Deep-learned AI for automated cardiac arrhythmia detection and analysis
Model · Cloud SaaSCompany source
Company profile
About iRhythm Technologies
iRhythm Technologies is a digital healthcare company specializing in ambulatory cardiac monitoring solutions. The company's flagship product line, Zio® ECG monitors, includes the Zio monitor and Zio AT devices designed for continuous, uninterrupted cardiac monitoring. The iRhythm monitoring service combines thoughtfully engineered wearable devices with FDA-cleared deep-learned AI algorithms and verification by Qualified Cardiac Technicians (QCTs) to deliver physician-ready reports with 99% physician agreement. The service includes the ZioSuite® portal for data management, seamless EHR integration, and the MyZio® patient app for patient support throughout the monitoring journey. iRhythm serves healthcare professionals across cardiology, electrophysiology, and primary care, as well as health plans and value-based care organizations. The company has analyzed over 12 million patients and processed over 2 billion hours of curated heartbeat data. Clinical studies demonstrate that the iRhythm LTCM (long-term continuous monitor) service achieves the highest diagnostic yield of specified arrhythmias and the lowest likelihood of retesting compared to other monitoring services. The company's technology enables accurate and timely diagnosis of arrhythmias while streamlining healthcare resource utilization and supporting cardiovascular program development.
Company description iRhythm Technologies official website
Mission. iRhythm is shaping the future of heart monitoring and empowering better health for all.
Primary marketRemote Patient Monitoring & Wearables
Commercial modelCommercial information available on request
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Arrhythmias
- Atrial fibrillation
- Cardiac rhythm disorders
Who it serves
- Cardiology and Electrophysiology practices
- Health Plans
- Health Systems
- Primary Care providers
- Value-Based Care organizations
Deployment & integration
Api Only · Cloud Saas · Embedded · Hybrid deployment with recorded integration context.
Recorded integration context: EHR Integration.
Geographic context
MarketsEurope · Japan · United Kingdom · United States
Company sourceOfficial website
Company milestones
Platform expansion
AVALON Study published in American Journal of Managed Care (2025) examining arrhythmia diagnosis, clinical outcomes, and healthcare resource utilization across commercially insured populations
Partnerships
Recorded partners
No partners are currently listed.
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
iRhythm AI Algorithm
FDA-cleared deep learning algorithm for arrhythmia detection
Model · Cloud SaaSCompany source
iRhythm Cardiac Monitoring Service
End-to-end cardiac monitoring service combining devices, AI, and clinical review
Service · HybridCompany source
iRhythm EHR Integration
Seamless integration with electronic health record systems
Software · Api OnlyCompany source
MyZio Patient App
Patient-facing mobile app for cardiac monitoring support and engagement
Software · Cloud SaaSCompany source
Zio AT
Advanced wearable cardiac monitor with real-time transmission capabilities
Device · EmbeddedCompany source
Zio monitor
Advanced wearable ECG patch for continuous cardiac monitoring
Device · EmbeddedCompany source
ZioSuite
Comprehensive clinician portal for cardiac monitoring data management
Platform · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
All-cause healthcare cost differences across ambulatory cardiac monitoring modalities in Medicare beneficiaries: a real-world claims-based study using entropy balancing.Journal of medical economics · Dec 1, 2026
PVC Variability and Impact on Meeting Expert Consensus Cutoffs of ≥ 10 000 PVCs/Day and ≥ 15% PVCs.Journal of cardiovascular electrophysiology · Jun 25, 2026
Considerations for Using Atrial Fibrillation Burden as a Surrogate Endpoint A Report from the Cardiovascular Sciences Research Consortium.American heart journal · Jun 22, 2026
Relationship of symptom frequency and symptom-rhythm correlation to arrhythmia type and time to detection: Insights from ambulatory electrocardiogram monitoring in over 1 million patients.Heart rhythm · Feb 1, 2026
Access to digital health technologies: personalized framework and global perspectives.Nature reviews. Cardiology · Jan 1, 2026
Real world evidence on health care resource utilization and economic burden of arrhythmias in patients with COPD.Journal of medical economics · Dec 1, 2025
Clinical validation
Clinical-trial records
No linked records are currently available.
Regulatory
Regulatory records
ZEUS Platform (FG0501US)K252859 · 510k · May 29, 2026
ZEUS SystemK222389 · 510k · Feb 15, 2023
ZEUS System (Zio Watch)K213409 · 510k · Jul 19, 2022
Zio ECG Utilization Software (ZEUS) SystemK202527 · 510k · May 21, 2021
Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemK190593 · 510k · Aug 23, 2019
Zio AT ECG Monitoring System, ZEUS SystemK181502 · 510k · Aug 29, 2018
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
99% physician agreement with end-of-wear reports
Comprehensive report accuracy
Near-perfect patient compliance
Patient adherence to monitoring protocol
Highest diagnostic yield of specified arrhythmias
Compared to other long-term continuous monitors
Lowest likelihood of retesting
Compared to other ambulatory cardiac monitoring services
Over 12 million patients analyzed
Total patient volume
Over 2 billion hours of curated heartbeat data
Data corpus for AI training and validation
AVALON Study - Commercially Insured Populations
Assessment of variation in ambulatory cardiac monitoring strategies examining how monitoring strategy influenced arrhythmia diagnosis, clinical outcomes, and healthcare resource utilization
Demonstrated superior clinical outcomes and resource utilization compared to other monitoring strategies
Commercially insured patient populations
Assessment of variation in ambulatory cardiac monitoring strategy influence on arrhythmia diagnosis, clinical outcomes, and healthcare resource utilization
Demonstrated impact on arrhythmia diagnosis and healthcare resource utilization through AVALON Study
Commercially insured patient populations (AVALON Study)
Assessment of variation in ambulatory cardiac monitoring strategies examining how monitoring strategy influenced arrhythmia diagnosis, clinical outcomes, and healthcare resource utilization
Demonstrated superior clinical outcomes and resource utilization compared to other ambulatory cardiac monitoring strategies
Medicare beneficiaries study
Comparative effectiveness and healthcare utilization for ambulatory cardiac monitoring strategies
Highest diagnostic yield of specified arrhythmias and lowest likelihood of retesting compared to other monitoring services
CAMELOT Study
Comparative effectiveness of ambulatory cardiac monitoring strategies in diagnostic-naïve patients
Superior clinical outcomes and healthcare cost efficiency compared to alternative monitoring strategies
Diagnostic-naïve patients (CAMELOT Study)
Comparative effectiveness of ambulatory cardiac monitoring strategies examining variations in ACM strategies, clinical outcomes and health care costs
Superior diagnostic yield and cost-effectiveness in diagnostic-naïve patients
Holter monitoring comparison study
Prospective study comparing detection of arrhythmia events over total wear time with Zio device versus 24-hour Holter monitoring
14-day Zio monitoring demonstrated superior arrhythmia detection compared to 24-hour Holter monitoring
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from iRhythm Technologies
Recent articles published on iRhythm Technologies's official website.
No Company updates are currently listed.
07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Remote Patient Monitoring & Wearables
Companies providing AI-powered remote patient monitoring solutions, wearable health devices with AI analytics, continuous health tracking, or platforms that monitor patients outside clinical settings. Includes general wellness wearables with AI coaching, respiratory monitoring devices, and connected health platforms that aggregate and analyze physiological data from sensors.
Explore the full market directory or compare this Company with additional active profiles.
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Expanded Company research is in development.
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Deeper Company research is coming soon.
Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.
Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.