News item

FDA Grants Marketing Clearance for the Peerbridge CorTM Multi-channel Remote ECG Monitor

Press Release

Peerbridge Health Inc., announced today that its first product, the Peerbridge CorTM System – a wireless electrocardiogram (ECG) monitor – has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). 

The patented Peerbridge Cor 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 New York’s Northwell Health System’s Lenox Hill Hospital evaluating it side-by-side to 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 Peerbridge Cor 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,” said Michael R. Gold, MD, PhD, FHRS, Professor of Medicine at the Medical University of South Carolina and immediate past president of the Heart Rhythm Society. “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 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,” said Arthur Bertolero, President and CEO of Peerbridge Health. “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 includes patient-activated event logging functionality and a dedicated handheld transmitter for event transmission on Holter, Event, and Extended Holter tests for up to 7 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).

The Cost of Cardiovascular Disease

The American Heart Association (AHA) reports cardiovascular disease as the top killer of American adults. Cardiovascular monitoring, both inside and outside medical environments, is critical for diagnosis, proper treatment, and improved outcomes.

According to the AHA, annual direct medical costs associated with cardiovascular diseases are projected to rise to more than $749 billion by 2035.1 When combined with indirect costs, cardiovascular costs can reach $1.1 trillion by 2035.1 To get ahead of the growth in patient demand, an increasing number of providers are looking for more efficient monitoring like Peerbridge Health’s technology to improve treatment and deliver better outcomes, which also has the potential to significantly reduce expenses.

According to research published in Circulation, the journal of the American Heart Associationexperts recommend screening for AF in older people to cut risk of stroke and death.

About Peerbridge Health

Peerbridge Health, Inc. is a mobile health software company headquartered in New York, NY. Peerbridge seeks to bring independence and precision to patients and physicians using remote monitoring capabilities for medical, wellness and performance-based needs including the monitoring of vital signs, applying thoughtful design and a commitment to a seamless user experience. The company has two digital health and fitness pioneering patents for medical grade monitoring of all vital signs, with other patents pending.

The founder of Peerbridge Health, Dr Angelo Acquista, MD had the vision in 2006 to remove the wires in hospital and outpatient settings for vital signs monitoring. Heart rate and heart rhythm is the first vital sign to be marketed by Peerbridge Health. The next generation of Peerbridge products, the Peerbridge CorHRV and Cor+, will monitor heart rate rhythm, respiratory rate, temperature, oxygen saturation, and HRV. Peerbridge is working with leading hospitals and mobile health companies to securely communicate across platforms to achieve Dr. Acquista’s vision.

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