Peerbridge Health has announced that its first product, the Peerbridge Cor System—a wireless electrocardiogram (ECG) monitor—has received 510(k) clearance from the US Food and Drug Administration (FDA). The patented device has the smallest on-body footprint of any wearable monitor while maintaining multiple channels of ECG and water-resistant electrodes for extended continuous monitoring.
The Peerbridge Cor was studied in an ambulatory ECG clinical trial at Northwell Health System’s Lenox Hill Hospital (New York, USA), evaluating it side-by-side to the traditional gold standard Holter monitor technology to evaluate the feasibility of capturing multi-channel diagnostic grade ECG in patients with atrial fibrillation (AF) and other arrhythmias. In the side-by-side single blinded comparison, the new technology demonstrated superiority to the Holter monitor.
“Early detection of atrial fibrillation and other arrhythmias is important to determine proper medical treatment, as these conditions are often silent and intermittent. They often become more difficult to treat as they progress.” says Michael R Gold, Medical University of South Carolina, USA. “From my perspective, the Peerbridge Cor clinical trial data and FDA marketing clearance represents the first technology that provides a true Holter monitoring replacement. This has significant importance for both patients and health professionals.”
The monitor includes patient-activated event logging functionality and a dedicated handheld transmitter for event transmission on Holter, event, and extended Holter tests for up to seven days. The Peerbridge Cor will deliver a quantitative analysis on every report, while delivering data accuracy to a point where individual rhythm complexes can be measured. (e.g. QT/QTc and HRV).