Technology | January 23, 2012

CardioComm Receives FDA Clearance for First Over-the-Counter Heart Monitoring Solution

January 23, 2012 — CardioComm Solutions, Inc. a provider of ECG acquisition and management software solutions, received clearance from the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) sales and marketing of their consumer-based, 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 that 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.

The HeartCheck Pen stores 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.  The GEMS Home software offers a simple software user interface for managing heart rhythm recordings and associated data.

“What makes this product unique,” explained Grima, “is that after a consumer sends a selected heart rate recording to the C4 medical call center over the internet using GEMS Home, 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.”

“Any person interested in monitoring their health for primary or secondary disease reasons would benefit from this solution,” stated Michael Baber, business development director for the HeartCheck brand.  CardioComm Solutions is now in the process of developing market channels for the distribution of this new device and service. 

“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,” reported Grima.  Anatoly Langer, M.D., chairman of the board for CardioComm Solutions confirms, “As a cardiologist, I believe this development represents the cutting edge of the intersection between medicine and technology.  Informed consumers who wish to have the freedom and the 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.” 

“A priority for the current year is the global commercialization of the HeartCheck Pen Handheld ECG Monitor and GEMS Home solution,” stated Grima.  “In association with the launch of this new offering, we are preparing for a financing round with an eye toward private placement.  Together with the anticipated completion of our new GEMS 4.0 platform, 2012 indeed promises to be an exciting time for CardioComm Solutions.”

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