The FDA granted Bardy Diagnostics 510(k) clearance for the 14-day version of its Carnation Ambulatory Monitor (CAM) patch, a wearable device used to diagnose arrhythmia and assist in patient management.
The extended wear version detects and records the P-wave, a small amplitude signal of the ECG originating in the heart’s upper chamber. The wave is important in accurately diagnosing arrhythmia, Bardy said.
The new version uses the same P-wave focused technology as the company’s two- and seven-day CAM patches. Its extended duration may help detect less frequent arrhythmias, the company said.