Bardy Diagnostics, a healthtech company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for the 14-day version of the Carnation Ambulatory Monitor (CAM), a P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device.

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

The breakthrough technology detects and records the P-wave, a small amplitude signal of the ECG originating in the atrium that is required to accurate arrhythmia diagnosis and patient management.

Bardy has engineered the CAM for optimal detection

Unlike other commercially available patches, the company has engineered the CAM for optimal detection and recording of the P-wave in relation to the rest of the ECG signal to deliver diagnostic accuracy.

The disruptive technology allows patients to mail the device back for analysis. Alternatively, the physician office can upload data from a patient’s monitor within several minutes after completion of a study.

The 14-day CAM patch allows up to double the duration of P-wave optimised detection and monitoring over the current 7-day patch, discovering additional, less-frequent arrhythmias.

The clinical value of P-wave focused detection was mentioned in the American Heart Journal, which published the results of a comparison with the iRhythm Zio XT patch.

According to the study, the BardyDx CAM patch identified 40% more arrhythmias and also resulted in more informed clinical decision-making in 41% of patients compared to the iRhythm Zio XT patch.

In a preceding study that compared the BardyDx CAM patch and a traditional Holter monitor, it found a four-fold increase in arrhythmia detection using the CAM patch, including arrhythmias missed or incorrectly identified using the Holter monitor.

BardyDx recently won the 2019 MedTech Breakthrough Award for Best New Diagnostic Technology and the winner of the 2019 Frost & Sullivan Award for Technology Innovation in Remote Cardiac Monitoring.

BardyDx founder and chief executive officer Gust Bardy said: “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.

“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.”