FDA Approves HeartCheck™ Pen Handheld ECG

CardioComm Solutions, Inc. has received clearance from the FDA for over-the-counter sales and marketing of their hand-held heart rhythm monitor known as the HeartCheck™ Pen Handheld ECG.

The FDA clearance also included CardioComm Solutions’ GEMS™ (Global ECG Management System) Home software, which enables the HeartCheck™ Pen to be connected to a personal computer to upload the heart rhythm recording to CardioComm Solutions’ C4 medical call service telemedicine group for review by a physician.

The HeartCheck™ Pen and GEMS™ Home solution provide an extension to the HeartCheck™ ECG Monitor solution, which may be used only under physician direction. Both devices can communicate with CardioComm Solution’s C4 medical call centre.

“Through this consumer product,” said Etienne Grima, CardioComm Solutions’ CEO, “we are truly putting people’s heart health into their own hands.” The Pen will display only the heart rate count until an interaction with a physician occurs. 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.

“We feel the HeartCheck™ Pen is a true remote monitoring device because it is compact, easy to use, and takes accurate heart readings in only 30 seconds. The Pen may be used from anywhere, including at home, the office, the gym or in remote areas which are often inaccessible to common ECG machines,” said Grima.

Source: BusinessWire