Health information technology company Peerbridge Health said this week it won FDA 510(k) clearance for its Peerbridge Cor wireless electrocardiogram monitor.
The New York-based company claims the Cor has the smallest on-body footprint of any wearable monitor and provides multiple channels of ECG through water-resistant electrodes to enable continuous monitoring.
Data from a clinical trial of the Cor device, carried out at New York’s Northwell Health System’s Lenox Hill Hospital, indicated that the wireless monitor was superior to a Holter Monitor, Peerbridge Health claims.
“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. 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,” Dr. Michael Gold of the University of South Carolina said in a prepared statement.
The system includes patient-activated event logging functionality as well as a dedicated handheld transmitter for event transmission on Holter, Event and Extended Holter tests for up to 7 days.
“The 510(k) clearance of our Peerbridge Cor ECG monitor is an exciting milestone and the 1st step in transforming and personalizing patient care through wireless multi-channel remote monitoring. The Peerbridge Cor has applications in both hospital and home settings that can enhance the patient experience and improve outcomes by providing continuous information to doctors and patients,” Peerbridge Health prez Arthur Bertolero said in a press release.