MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
InfoBionic, Inc.The MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System is a wearable cardiac monitoring device for patients with suspected arrhythmias. It captures ECG data through a sensor pod with leads or a patch, which is wirelessly transmitted to a mobile gateway and then to a cloud-based software platform for analysis using proprietary algorithms. This helps physicians detect and monitor cardiac arrhythmias, aiding in diagnosis and treatment decisions without requiring patient intervention during use.
Intended Use
MoMe ARC Wireless Ambulatory ECG Monitoring and Detection System is intended for monitoring patients with suspected cardiac arrhythmias to aid in detection and diagnosis as prescribed by a physician.
Technology
The system consists of a body-worn Sensor Pod with leads or patch acquiring ECG data, a Gateway mobile device that wirelessly transmits data via Bluetooth and cellular network to a cloud-based software platform which analyzes data using proprietary algorithms to detect arrhythmias and flags data for physician review.
Performance
Performance testing includes conformance with multiple recognized standards for safety and performance of ambulatory ECG systems and electrical medical devices. Clinical testing with 87 subjects demonstrated sensitivity and positive predictivity of the AI algorithm for arrhythmia detection meeting acceptance criteria, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/7/2025
5 months - 2
FDA Approval
7/29/2025
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