CardioComm HeartCheck Pen Handheld ECG wins OTC approval from FDA

CardioComm Solutions has received an over-the-counter (OTC) sales approval for its HeartCheck Pen Handheld ECG from the US Food and Drug Administration (FDA).

In addition, the company also received FDA clearance for its Global ECG Management System (GEMS) Home software.

CardioComm said the HeartCheck Pen provides accurate heart readings in only 30 seconds and can stores up to 20 ECGs, and its data can be downloaded to GEMS Home.

CardioComm Solutions CEO Etienne Grima said the consumer sends a selected heart rate recording to the C4 medical call center over the internet using GEMS Home, then the actual ECG recording will be reviewed and interpreted by an attending C4 physician.

"The ECG report will then be made available to the customer, again through GEMS Home, where they may retrieve the ECG interpretation and use it in communicating with their own health care providers," Grima said.

"Once a C4 physician has provided review and feedback to the customer, the Pen's screen can be unlocked to display the real-time ECG and heart rate count for subsequent heart rhythm recordings."

CardioComm Solutions said it is now in the process of developing market channels for the distribution of this new device and service.