TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE: EKG) (“CardioComm” or the “Company”), a leading global medical provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, has received approval from the US Food and Drug Administration (“FDA”) for the over-the-counter (“OTC”) sales and marketing of their device agnostic GEMS™ Mobile smartphone app and their newest handheld, heart rhythm monitor, the HeartCheckTM CardiBeat. Both have been cleared as a Class II medical device and are available for sale direct to consumers.
Of significance is the GEMSTM Mobile smartphone app, a slimmed down version of the Company’s hospital-based software named Global ECG Management System (GEMSTM). In addition to supporting CardioComm’s own CardiBeat device, GEMS™ Mobile is the only ECG management iOS and Android smartphone app that has the ability to connect to several different manufacturers’ ECG monitoring devices. The first release of GEMS™ Mobile will give people the choice to work with up to two other handheld ECG monitors, both of which are already cleared for sale by the FDA in the US.
CardioComm was the first company to bring an ECG device and software to market for direct to consumer sales in North America and to enable anyone to see their ECG without a physician prescription. Software is the keystone element for such innovations and CardioComm expects to leverage the GEMS™ Mobile app in bringing new and additional advancements to personalized health and remote patient monitoring solutions.
The Bluetooth enabled and rechargeable CardiBeat allows a medical grade ECG recording to be taken by holding the device in both hands or by holding the device in the right hand and against the left side of the chest. This second option is more accurate for diagnosing arrhythmias such as atrial fibrillation and atrial flutter. This represents a significant diagnostic advantage over other devices currently on the market.
GEMS™ Mobile allows Smartphones and tablets to receive ECGs from HeartCheck™ devices for post-event or real-time/continuous cardiac monitoring. Feedback through the app is near-real-time and allows the user to view and generate a report of their own ECG which may be automatically shared with one’s physician. For those who want their ECGs reviewed, GEMS™ Mobile provides access to CardioComm’s SMART Monitoring ECG reading service for a professional review of the ECG for the presence of a number of potential arrhythmias.
GEMS™ Mobile is expected to be available on Apple’s App Store and on Google Play in March and will be free with the purchase of a HeartCheckTM ECG device. Pricing of the HeartCheckTM CardiBeat will be announced shortly.
To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations please visit the Company’s websites at www.theheartcheck.com and www.cardiocommsolutions.com.
