Innovation Continues as the #FDA Clears CardioComm Solutions' (TSXV: EKG) Novel ECG Smartphone App and Heartcheck(TM) Device for Direct to Consumer Sales
The HeartCheck(TM) CardiBeat and GEMS(TM) Mobile App Supports Both iOS and Android Smartphones for use in Consumer, Clinical Research and Telemedicine Cardiac Monitoring Solutions
Toronto, Ontario - February 25, 2019 (Newsfile Corp.) (Investorideas.com Newswire) CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a leading global 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, GEMSTM 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 GEMSTM 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 see the Company's websites at www.theheartcheck.com and www.cardiocommsolutions.com.
About CardioComm Solutions
CardioComm Solutions' patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. CardioComm Solutions has earned the ISO 13485 certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).
FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
This release may contain certain forward-looking statements and forward-looking information with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. Such statements and information reflect management's current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements and forward-looking information.
In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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