Frontier X Plus
Fourth Frontier Technologies Pvt LtdFrontier X Plus is a wearable ECG event recorder that monitors heart rhythms by capturing single-channel ECG signals via a chest strap. It automatically analyzes the ECG data using an embedded algorithm to detect arrhythmias such as atrial fibrillation, bradycardia, and tachycardia. The device helps clinicians monitor and diagnose heart conditions in adult patients, particularly those with suspected or known cardiac issues, by storing and transferring ECG data for physician review.
Intended Use
The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel ECG rhythms for monitoring and evaluation, including rhythm analysis to detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythms in adult patients.
Technology
The device records single-channel ECG via dry electrodes embedded in a chest strap and transmits the signal wirelessly to embedded firmware using the HeartKey ECG algorithm for rhythm analysis and display. It operates via Bluetooth with iOS and Android software interfaces and uses a proprietary algorithm to detect cardiac rhythms such as atrial fibrillation and tachycardia.
Performance
Performance testing included cybersecurity, software verification and validation, signal integrity, and clinical investigation involving 832 patients comparing device ECG waveforms with standard 12-lead ECGs. The clinical study demonstrated substantial equivalence to predicate devices in detecting atrial fibrillation, normal sinus rhythm, bradycardia, tachycardia, and other rhythms. The device meets ISO and IEC standards for safety and performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/22/2024
7 months - 2
FDA Approval
11/8/2024
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