ZEUS System
iRhythm Technologies, Inc.The ZEUS System by iRhythm Technologies is a software platform designed to analyze ECG data from wearable cardiac monitors to detect arrhythmias and other heart rhythm abnormalities. It uses AI algorithms to automatically process and identify cardiac events, assisting clinicians in diagnosing and managing heart conditions by generating detailed reports from long-term ECG recordings.
Intended Use
The device is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram information for long-term monitoring in patients 18 years or older.
Technology
The system is software-based, utilizing AI algorithms including an AutoTrigger Engine and ECGDL software to analyze ECG data from wearable monitors, automatically detecting arrhythmias and cardiac rhythms, with results reviewed by technicians before report generation.
Performance
The device underwent design verification and validation testing demonstrating conformance with FDA-recognized standards for risk management, software lifecycle, and ambulatory ECG safety and performance, confirming substantial equivalence to predicate devices without new safety or efficacy concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/8/2022
6 months - 2
FDA Approval
2/15/2023
Other devices from iRhythm Technologies, Inc.
- ZEUS System (Zio Watch)2022 • 510K
- Zio ECG Utilization Software (ZEUS) System2021 • 510K
- Zio XT ECG Monitoring System, Zio AT ECG Monitoring System2019 • 510K
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