New York-based Peerbridge Health announced that its wireless device, dubbed the Peerbridge Cor System, is the latest ECG device to receive 510(k) clearance from the FDA. According to the company, the device has the smaller on-body footprint of any wearable, multi-channel ECG with water-resistant electrodes.
“The 510(k) clearance of our Peerbridge Cor ECG monitor is an exciting milestone and the first step in transforming and personalizing patient care through wireless multi-channel remote monitoring," Arthur Bertolero, president and CEO of Peerbridge Health, said in a statement. "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.”
The Peerbridge Cor can be worn for as many as seven days, and included a patient-activated event logging feature as well as a dedicated handheld transmitter for event transmission. In an ambulatory ECG clinical trial at New York’s Northwell Health System’s Lenox Hill Hospital, the newly-cleared device, investigators found Peerbridge’s device to be superior to the gold standard when capturing multi-channel diagnostic grade ECG in patients with atrial fibrillation and other arrhythmias.
“Early detection of atrial fibrillation and other arrhythmias is important to determine proper medical treatment, as these conditions are often silent and intermittent,” Dr. Michael R. Gold, professor of medicine at the Medical University of South Carolina and prior president of the Heart Rhythm Society, said in a statement. “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.”
Peerbridge is similar in some ways to another recently cleared ECG device, NimbleHeart’s Physiotrace Smart. The fully reusable ECG device relies on no electrolytic gels or adhesives, and is designed for home use.
Other players in this field also iRhythm's Zio patch and Vital Connect's VitalPatch, both of which are adhesive-reliant. iRhythm filed with the SEC to raise up to $86 million in an initial public offering last year, while Vital Connect collected $10.6 million in funding for its disposable monitors around the same time.