Bardy Diagnostics has received 510(k) clearance from the FDA for a 14-day version of the Carnation Ambulatory Monitor (CAM), which a press release says is market’s only 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 use the same P-wave focused technology that powers the existing two-day and seven-day CAM product lines.

The CAM patch’s technology is designed to reliably detect and records the P-wave. The press release adds that unlike other commercially available patches that include licensed, acquired, or off-the-shelf technologies, the CAM was specially engineered by BardyDx engineers for optimal detection and recording of the P-wave in relation to the rest of the ECG signal to deliver industry leading diagnostic accuracy.

The new 14-Day CAM patch enables up to double the duration of P-wave optimised detection and monitoring over the current 7-Day CAM patch, potentially discovering additional, less-frequent arrhythmias. A study published in the American Heart Journal comparing the CAM patch with the Zio XT patch (iRhythm) concluded that the BardyDx CAM patch identified 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients compared to the iRhythm Zio XT patch.

Gust H Bardy, found and CEO of BardyDx, says: “Comfortable dermal ECG recordings that focus on the P-wave for up to 14 days carry the potential to minimise 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.”