www.fdanews.com/articles/197316-two-week-ambulatory-cardiac-patch-earns-ce-marking
Two-Week Ambulatory Cardiac Patch Earns CE Marking
May 28, 2020
Bardy Diagnostics has received CE mark certification for the two-week version of its Carnation Ambulatory Monitor (CAM) patch, a cardiac monitoring device used to detect arrythmias.
The device is placed on the chest to monitor a patient’s electrocardiogram (ECG) signal. Its longer duration enables clinicians to detect less-frequently occurring arrythmias.
The device was previously cleared by the FDA in two- and seven-day versions.