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.
To resolve this issue, Bardy Diagnostics (BardyDx) has been developing robust ambulatory cardiac monitoring technologies from the last few years. The company recently announced a 510 (k) clearance from the US FDA for its 14-day version of the Carnation Ambulatory Monitor (CAM), the industry's only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device.
The award-winning CAM patch is offered in a 14-day extended wear version, which utilizes the same innovative P-wave focused technology leveraged by the existing 2-day and 7-day CAM product lines. Besides, the device will enable clinicians to achieve greater flexibility in cardiac monitoring over a more extended period.
Gust H. Bardy, MD, Founder & CEO of BardyDx, said, "Comfortable dermal ECG recordings that focus on the P-wave for up to 14 days carry the potential to minimize the use of costly additional rhythm diagnostic tools. We are excited to receive clearance from the FDA to enable clinicians the option to monitor longer and anticipate incremental detection of accurate, medically actionable data to improve patient management."
An innovator in digital health and remote patient monitoring, BardyDx delivers diagnostically-accurate and patient-friendly cardiac patch monitors to the industry. Its CAM patch is a non-invasive, P-wave centric ambulatory cardiac monitor and arrhythmia detection device designed to enhance patient compliance for adults and children. The device can be worn comfortably and discreetly. The female-friendly, hourglass-shaped CAM patch can be placed on the center of the chest, directly over the heart for optimum ECG signal collection. The proprietary technology of the CAM patch delivers optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform essential for accurate arrhythmia diagnosis.
The breakthrough technology leveraged by the CAM patch detects and records the P-wave, the small amplitude signal of the ECG originating in the atrium. It is essential for accurate arrhythmia diagnosis and patient management. Specially engineered by experts at BardyDx, the device offers optimal detection and recording capability, delivering industry-leading diagnostic accuracy. The critically acclaimed technology provides clinicians with seamless functionality with its workflow-friendly design. The patients can not only mail the device to the physician for analysis, but the data from the monitor can be uploaded within a matter of minutes.
The 14-day CAM patch provides an extended duration for P-wave optimized detection and monitoring, potentially leading to the discovery of less-frequent arrhythmias. The American Heart Journal explored the clinical value of P-wave focused detection in the results of its comparison study and concluded that the product of BardyDx CAM patch identified 40 percent more arrhythmias and facilitated more informed clinical decision making in 41 percent of the patients when compared to the iRhythm Zio XT patch. A similar study which compared the product to the Holter monitor revealed a four times rise arrhythmia detection in favor of the BardyDx CAM patch. The outcomes show that the CAM patch offers significantly higher diagnosis results.
Ken Nelson, the Chief Commercial Officer at BardyDx, said, "Combining the excellence of our proven P-wave technology with the capability of longer duration monitoring produces an unmatched cardiac monitoring solution. We are excited to offer a 14-Day CAM patch that truly provides value for clinicians and patients alike."
The P-wave centric CAM patch is establishing its dominance in the crowded market of cardiac monitoring patch entrants. It has garnered acclaim through various awards, including the 2019 MedTech Breakthrough Award for Best New Diagnostic Technology, the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring. BardyDx has also been named the winner of the Impact Pediatric Health Competition hosted by the leading pediatric healthcare institutions of the nation at SXSW 2019.