Peerbridge Cor(TM) System

The Peerbridge Cor™ System is an ambulatory electrocardiogram (ECG) monitoring device designed for continuous 2-channel ECG recording for up to seven days, or patient-activated event capture, in adult patients. It employs a wearable sensor, a handheld transmitter for symptomatic event reporting, and a cloud-based platform with FDA-cleared algorithms to generate ECG reports for clinician review, supporting the assessment of transient cardiac symptoms.

The Peerbridge Cor™ System is an ambulatory wearable electrocardiogram (ECG) monitoring system designed to record and provide a patient's ECG data to clinicians. It comprises two models, Cor™ XT and Cor™ Event, which utilize five main components: a wearable ECG sensor with Bluetooth, an adhesive electrode, a dedicated handheld transmitter, a data upload fixture and software for transferring ECG data to a PC and then to a cloud-based backend data management module. The system continuously collects two channels of ECG data for up to seven days. Patients can also report symptomatic events by pressing a button on the sensor or using a mobile application on the handheld transmitter. It is intended for adult patients (18 years or older) who may be asymptomatic or experience transient symptoms like palpitations, shortness of breath, or dizziness. The system supports three types of tests based on medical necessity: 24-hour Holter monitoring (Cor XT and Cor Event), up to 7-day Holter monitoring (Cor XT), and Patient Activated Event with Surveillance (Cor Event), initiated by a clinician via the Peerbridge Portal. The generated ECG reports, which support 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement, and rhythm analysis by FDA-cleared algorithms, are provided for clinician review and do not offer diagnostic interpretations. Non-clinical testing, including software validation, biocompatibility, electrical safety, electromagnetic compatibility, defibrillation safety, sensor functional testing, wearability, and human factors/usability testing, demonstrated that the device meets its performance requirements.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the storage capacity of the Wearable ECG Sensor and how are data integrity and transmission ensured, especially during the maximum 7-day recording period?; Can the system distinguish between motion artifacts and true arrhythmic events, and what mechanisms are in place to minimize false positives in the generated ECG reports?; What are the specific performance metrics (e.g., sensitivity, specificity) of the FDA-cleared algorithms used for beat-by-beat analysis and rhythm analysis within the Peerbridge Cor™ System?; How does the "Data Upload Fixture and Software" facilitate the transfer of ECG data from the Wearable ECG Sensor to the PC and then to the Backend, and what are the typical upload times for a full 7-day recording?; What specific differences in "post-data acquisition clinical workflow" distinguish the Peerbridge Cor™ XT model (offering up to 7 days of Holter monitoring) from the Cor™ Event model (offering Patient Activated Event with Surveillance)?