Home > CardioVascular > Vendors > Bardy Diagnostics, Inc.

Bardy Diagnostics, Inc.: Game-Changers in Cardiac Monitoring

CIO VendorKen Nelson, Chief Commercial Officer
Life-threatening cardiac arrhythmias are recognized as critical cardiac disorders that can impair the heart’s ability to pump enough blood, resulting in death. Traditional cardiac monitors are large, bulky, and uncomfortable and typically record noisy signals, proving ineffective at accurately providing user-friendly arrhythmia diagnosis and monitoring. Dr. Gust Bardy, an established electrophysiologist with decades of experience in designing cardiac devices and possessing over 200 U.S. patents, took up the task of completely redesigning arrhythmia monitors with optimal signal detection, comfort, and ease of use. The source of his dedication was due to the loss of his wife to a rare heart rhythm disorder that was not identified using traditional cardiac monitors. He founded Bardy Diagnostics to assist physicians in the accurate diagnoses and treatment of arrhythmia-related cardiac diseases and prevention of sudden cardiac death.

The company’s Carnation Ambulatory Monitor (CAM™) patch is a non-invasive P-wave centric arrhythmia detection device. It is the P-wave that is central to understanding an arrhythmia’s origin. The CAM patch’s P-wave focused technology has an extremely low noise floor of 2.5 microvolts, which enables recognizing the often difficult-to-detect P-wave, thus delivering optimal ECG clarity unlike traditional Holter monitors. Chief Commercial Officer at Bardy Diagnostics, Ken Nelson explains, “It is like competitive products look at a P-wave through binoculars, and we can view the P-wave through a microscope.” In addition, the CAM patch provides visualization of the R-waves (correlating ventricular rhythm) as well, enabling accurate and definitive arrhythmia diagnosis. Furthermore, CAM patch’s diagnostic accuracy is substantiated by head-to-head clinical trials against Holter monitors and other competitive products.

The unique narrow hourglass shape of the patch is well-suited for placement upon the sternum directly over the atria for optimum recording.

The CAM patch offers three market-leading competitive advantages of advanced diagnostic accuracy, patient-friendly design, and physician-friendly flexibility


The CAM patch can be comfortably and discreetly worn by men, women, and children, while improving patient compliance with its lifestyle-enabling patch design that permits exercising, sleeping, and showering while the device is worn. It is the only device designed to be comfortable for women. In addition, the product is available in 48-hour and 7-day recording options to provide physician-friendly flexibility. “The CAM patch offers three market-leading competitive advantages of advanced diagnostic accuracy, patient-friendly design, and physician-friendly flexibility,” says Nelson.

As an example, deploying Bardy Diagnostics’ services has enabled a renowned pediatric academic hospital to identify in their patient population previously undiagnosable arrhythmias using traditional monitors, like atrioventricular reentrant tachycardia (AVRT) and AV node reentrant tachycardia (AVNRT). In addition, the CAM patch design has drastically improved patient compliance in this pediatric group. As a result, institutions are now able to effectively diagnose and more quickly determine the appropriate procedure or intervention for their pediatric patients.

Unlike certain rivals, Bardy Diagnostics also offers multiple options for scanning, generating reports, and reviewing of data in-house without the frustrations of outsourcing. The company also provides download stations to Emergency Departments (EDs) where patients with significant arrhythmias requiring emergency medical attention can download their data in the ED and send it to the company for timely creation of reports, while some of Bardy Diagnostics’ competitors may entail a long duration for the same process.

Dr. Bardy envisions bringing P-wave centric monitoring to all forms of cardiac monitoring from 24 hours up to 30 days. He aspires to build AI-based, expert-validated products to consistently and objectively provide accurate diagnoses to providers and their patients. In the world of digital health, Bardy Diagnostics passionately believes in its potential to be the vanguard of cardiac monitoring patches alongside, “developing a more robust product portfolio within not only the cardiac monitoring space but also the vital signs monitoring space as well,” concludes Nelson.

Bardy Diagnostics, Inc. News

FDA Grants 510 (k) Clearance for BardyDx’s CAM Patch

The clearance will enable cardiovascular patients to avail the complete diagnostics capabilities of the breakthrough product.

FREMONT, CA: Cardiac arrhythmia is a critical cardiac disorder which can impair the ability of the heart to pump blood, and this can even lead to death. In such cases, heart monitoring becomes necessary. However, conventional cardiac monitors are not only large and bulky but are quite uncomfortable and record unnecessary noise that can affect diagnosis and monitoring. Read More