FDA-Cleared AI Algorithm
Deep-learned AI for automated cardiac arrhythmia detection and analysis
Company profile
Company profile
iRhythm Technologies is a digital health company that provides ambulatory cardiac monitoring services, including AI-assisted ECG analysis for arrhythmia detection.
Company description iRhythm Technologies official website
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Cloud Saas · Embedded · Hybrid deployment with recorded integration context.
Recorded integration context: EHR Integration.
Company milestones
AVALON Study published in American Journal of Managed Care (2025) examining arrhythmia diagnosis, clinical outcomes, and healthcare resource utilization across commercially insured populations
Partnerships
No partners are currently listed.
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
Deep-learned AI for automated cardiac arrhythmia detection and analysis
End-to-end cardiac monitoring service combining devices, AI, and clinical review
Patient-facing mobile app for cardiac monitoring support and engagement
Advanced wearable cardiac monitor with real-time transmission capabilities
Advanced wearable ECG patch for continuous cardiac monitoring
Comprehensive clinician portal for cardiac monitoring data management
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
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
NCT07205367 · Sponsor · COMPLETED
Pediatric Adhesion and New Dermal Approach StudyNCT07118124 · Sponsor · COMPLETED
Metabolic Surgery for Atrial Fibrillation EliminationNCT07027969 · Sponsor · NOT YET RECRUITING
Surveillance Trial of the Apple Watch in Reliable Burden Assessment in Unseen Recurrence of Surgically Treated AFNCT07122947 · Mentioned · RECRUITING
Trial Assessing the Effectiveness of Ivabradine Started at Discharge From the Observation UnitNCT03168529 · Sponsor · TERMINATED
Atrial Fibrillation Occurring Transiently With Stress (AFOTS)NCT03221777 · Mentioned · COMPLETED
Regulatory
K222389 · 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
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
Comprehensive report accuracy
Patient adherence to monitoring protocol
Compared to other long-term continuous monitors
Compared to other ambulatory cardiac monitoring services
Total patient volume
Data corpus for AI training and validation
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
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
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
Comparative effectiveness of ambulatory cardiac monitoring strategies in diagnostic-naïve patients
Superior clinical outcomes and healthcare cost efficiency compared to alternative monitoring strategies
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
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 profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Recent articles published on iRhythm Technologies's official website.
No Company updates are currently listed.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
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.
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