CardioComm Solutions Inc. filed a 510(k) application with the U.S. Food and Drug Administration, seeking approval for its heart rhythm monitor, HeartCheck.
The device allows the user to do a medical grade electrocardiogram recording by holding the device in the right hand and against the left side of the chest.
The company said the rechargeable and Bluetooth-enabled device will be named HeartCheck Cardi Beat and marketed as the HeartCheck Beat.
Toronto-based CardioComm Solutions develops software and hardware products, as well as core laboratory reading services, related to electrocardiogram and ambulatory arrhythmia monitoring systems.
