Peerbridge Cor(TM) System
Peerbridge Health INc.The Peerbridge Cor System is a wearable ECG monitoring device designed for continuous recording and transmission of heart electrical activity over 24 hours to 7 days. It helps clinicians monitor patients with symptoms like palpitations or dizziness by generating ECG reports based on FDA-cleared algorithms, aiding clinical diagnosis.
Intended Use
The Peerbridge Cor System is intended to capture and transmit symptomatic events and continuous external electrocardiogram (ECG) information for 24 hours and up to 7 days monitoring in adult patients with transient cardiac symptoms.
Technology
The device consists of a wearable ECG sensor with Bluetooth, adhesive electrodes, a handheld transmitter, data upload software, and a cloud-based data management backend. It records 2-channel ECG data continuously for up to 7 days and supports patient-activated symptomatic event recording. Analysis uses FDA-cleared algorithms generating reports for clinicians.
Performance
The device passed non-clinical, bench tests including software validation, biocompatibility, electrical safety, defibrillation safety, sensor functional testing, wearability, and summative human factors/usability testing. Clinical testing was not provided.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2017
3 months - 2
FDA Approval
9/27/2017
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