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Medical Devices / Submissions and Approvals

Bardy’s 14-Day Ambulatory Cardiac Patch Monitor Cleared

Sept. 11, 2019
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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.

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