We're close to your heart.

Gust H. Bardy, MD

Problem Tech Solves

Surprisingly, despite being utilized for over 50 years, current cardiac monitors do a poor job of visualizing the P-wave. Current solutions in the ambulatory cardiac monitoring space typically have unreliable recordings, poor patient compliance, and poor sensitivity. In addition, they are often not optimal for pediatric and female populations. Until recently, little focus has been placed on the cost, anxiety, and potential therapeutic consequences of a false-positive diagnosis resulting from legacy technology. The CAM patch advances monitoring through its proprietary P-wave sensing technology. It is the only product to address the long-standing complaint by cardiac physicians regarding their frequent inability to clearly distinguish the P-wave on ECG strips of existing modalities. The P-wave, a small amplitude signal originating in the atrium that is essential to arrhythmia diagnosis and the determination of appropriate medical or procedural intervention, is often unreliably detected or recorded by current technologies, resulting in inaccurate, vague, or missed diagnoses. As a non-invasive patch monitor applied to the chest over the atria, the CAM patch employs a novel, state-of-the-art sensing technology that incorporates low-noise circuitry designed for the optimal detection and recording of the P-wave. The CAM patch is specifically seeking to improve the accuracy of arrhythmia detection and accuracy of identification. Not only does the monitor seek to better detect and capture abnormal rhythms, but the technology developed in the patch product is designed to provide the best visualization of a heart’s rhythm, so a clinician can accurately and definitively diagnose the heart rhythm issue at hand.

Tech Brief

Bardy Diagnostics’ Carnation Ambulatory Monitor (CAM) is the only P-wave-centric ambulatory cardiac patch monitor and arrhythmia detection device. CAM provides an optimal recording of the often difficult-to-detect P-wave, the signal of the ECG essential for accurate arrhythmia diagnosis and is designed to be comfortable and discreet to improve patient compliance. BardyDx provides customers optimal flexibility for its web-based patient management portal, BDxCONNECT to fit into and streamline their existing workflows. Using this portal, clinicians can easily upload patient ECG data for analysis and retrieve completed reports prepared by BardyDx’s certified ECG technicians. The portal has been developed and continues to evolve to enable EMR integration to further streamline workflow efficiency and provide timely results, which is critical for relaying of results that may impact or define appropriate care and subsequent procedures. Not only does our solution provide superior precision to physicians with unparalleled ECG clarity through our unique and proprietary report format for improved clinical decision making, but we also offer a convenient Mail-to-Patient Program (MTP). Physicians can easily prescribe a CAM patch for a patient, through BDxCONNECT, and opt for a home application where a CAM will be mailed directly to a patient to be worn bypassing issues with access. The data from the CAM patch is recorded and then mailed back to our ECG monitoring center. The results are provided by our trained technicians and then easily communicated back to a clinician to follow up with the patient.

Tech Differentiators

In a relatively stagnant field void of innovation, the novel CAM patch addresses a long-standing complaint by physicians regarding their frequent inability to distinguish the P-wave on ECG strips of existing modalities. CAM patch’s innovative P-wave-centric technology offers unparalleled diagnostic accuracy and provides physicians confidence in diagnosing. BardyDx has quickly set itself apart from its cardiac monitoring patch competition since its launch in 2015. While the market has remained relatively stagnant in innovation for decades, aside from improvements in the form factor of traditional ambulatory ECG monitors (e.g., Holters, event monitors) to a patch by iRhythm, BardyDx has focused on reengineering the cardiac monitor to drastically improve the subpar quality and resolution of today’s ambulatory monitoring. Additionally, the CAM patch’s industry-leading diagnostic accuracy avoids these issues and, thus, reduces the cost of healthcare. Some tests provide vague, or inaccurate results. These contributing factors are observed with the use of Holter monitors, and the use of many other non-P-wave specific patch products. The improved diagnostic accuracy enabled by the CAM patch has allowed physicians to identify more arrhythmias and to avoid erroneous clinical decisions brought about by incorrect or incomplete arrhythmia identification. For example, atrial fibrillation is sometimes misdiagnosed using poor resolution holters, resulting in the patient having unnecessary pulmonary vein isolation ablation procedures. It isn’t until the procedure is performed and the arrhythmia found again that the physician realizes atrial fibrillation may not have been the issue. Wasted dollars on erroneous diagnostics and therapeutic procedures pile up.


A study titled, “Continuous ECG Monitoring Versus Mobile Telemetry: A Comparison Of Arrhythmia Diagnostics Between Human And Algorithm Dependent Systems” recently compared the diagnostic accuracy between human-oversight-dependent continuous ECG monitoring (The Cam patch) and algorithm-dependent mobile cardiac telemetry (MCT). 50 sequential patients wore the MCT and a long-term continuous ECG patch monitor simultaneously. Each study and associated report were reviewed by two electrophysiologists and categorized whether significant clinical arrhythmias were correctly diagnosed. The study demonstrated that twice as many patients were diagnosed with significant arrhythmias using continuous ECG monitoring. • 7/46 (15%), VT was reported by MCT, compared to 13/46 (28%) patients by LT-ECG monitoring. • 3 patients, 2° AV block was unreported by MCT but captured by LT-ECG monitoring. • 2 patients, AV node re-entrant tachycardia, captured by LT-ECG monitoring was missed by MCT. The study concluded that human-oversight dependent continuous ECG recordings significantly outperformed algorithm-dependent MCT recordings in the same patients over the same time-period. https://www.bardydx.com/wp-content/uploads/2021/07/DN000497A-Continuous-ECG-vs.-MCT-HRS-Summary-Sheet.pdf In a clinical study by Overlake Medical Center titled, “Accelerating Proper Evaluation of Emergency Department Patients for Arrhythmia Concerns with Discharge Use of ECG Patch Monitors,” CAM patch was applied to 412 patients in the Emergency Department (ED) over 2 years. As a result, the average discharge to diagnosis time was just 7 versus the previous 21-day average. In addition, ED patient readmissions within 30 days of the initial visit decreased to 7% compared to 40% of patients who had the same type of cardiac complaints in the previous year prior to CAM availability. https://www.bardydx.com/cam-patch-emergency-department-clinical-study/

Why Us

Rather than relying on algorithm-dependent technology, the unique CAM patch’s human-oversight continuous ECG recordings focus on solving unmet-needs of cardiac specialists regarding their inability to clearly distinguish the P-wave on ECG strips of existing modalities, resulting in inaccurate, vague, or missed diagnoses that can be extremely costly to the practice.

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