FDA Clears 14-Day Carnation Ambulatory Monitor Patch

Seattle-based Bardy Diagnostics, Inc., a provider of ambulatory cardiac monitoring technologies and custom data solutions, announces that it has received 510(k) clearance from the U.S. FDA for the 14-day version of the Carnation Ambulatory Monitor (CAM), a P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device.

Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the CAM patch will now be offered in a 14-day extended wear version that utilizes the same P-wave focused technology that powers the existing 2-day and 7-day CAM product lines.

“Comfortable dermal ECG recordings that focus on the P-wave for up to 14 days carry the potential to minimize use of costly additional rhythm diagnostic tools,” says Gust H. Bardy, MD, founder and CEO of BardyDx. “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.”

The CAM patch’s technology detects and records the P-wave, a small amplitude signal of the ECG originating in the atrium that is essential to accurate arrhythmia diagnosis and patient management. Moreover, the technology allows patients to mail the device back for analysis or the physician office to upload data from a patient’s monitor within several minutes upon completion of a study.

“Combining the excellence of our proven P-wave technology with the capability of longer duration monitoring produces an unmatched cardiac monitoring solution,” says Ken Nelson, BardyDx chief commercial officer. “We are excited to offer a 14-day CAM patch that truly provides value for clinicians and patients alike.”

http://www.24x7mag.com/2019/09/fda-clears-14-day-carnation-ambulatory-monitor-patch/