CardioComm Solutions has gained marketing clearance from the US Food and Drug Administration (FDA) for its consumer-based, hand-held heart rhythm monitor, the HeartCheck Pen handheld ECG.
The FDA clearance also includes the company’s Global ECG Management System (GEMS) Home software, which allows the HeartCheck Pen to be connected to a personal computer to upload the heart rhythm.
The pen can store up to 20 ECGs and its data can be downloaded to GEMS Home, where repeated recordings can be managed in a personal health data record.
CardioComm Solutions CEO Etienne Grima said the pen will display only the heart rate count until an interaction with a physician occurs. When a C4 physician provides 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," Grima added.
"Our cycle time for bringing this product to its current market-ready stage has been less than 14 months and we intend to keep the momentum going."
CardioComm Solutions Business Development director for the HeartCheck brand Michael Baber said the solution will benefit people interested in monitoring their health for primary or secondary disease reasons.
CardioComm Solutions chairman Anatoly Langer said they believe this development represents the cutting edge of the intersection between medicine and technology.
”Informed consumers who wish to have the freedom and security of monitoring their health will welcome being connected when they wish to access the expertise that comes with our leading ECG management software GEMS," Langer added.
CardioComm’s patented and proprietary technology is used in products for recording, viewing, analysing and storing ECGs for diagnosis and management of cardiac patients.