CardioComm Solutions Files with Health Canada for Direct to Consumer Sales Approval of the Heartcheck(TM) Cardibeat Handheld ECG Device
Bluetooth Connected HeartCheck CardiBeat and GEMS Mobile Smartphone App to Target Underserviced Canadian Home and Telemedicine Arrhythmia Monitoring Markets
Toronto, Ontario--(Newsfile Corp. - April 9, 2019) - CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a global provider of consumer heart monitoring and electrocardiogram ("ECG") acquisition and management software solutions, has filed with Health Canada for approval for the over-the-counter ("OTC") sales and marketing of their GEMS™ Mobile smartphone app and their newest handheld, heart rhythm monitor, the HeartCheck™ CardiBeat. Both were cleared by the Food and Drug Administration ("FDA") in early 2019 and are available for sale direct to consumers in the US.
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. The GEMS™ Mobile smartphone app is a slimmed down version of the Company's hospital-based Global ECG Management System ("GEMS™") software, which is separately cleared by Health Canada and licensed by 19 Canadian Hospitals.
GEMS™ Mobile manages ECGs recorded by HeartCheck™ devices and provides near-real-time feedback through the generation of an ECG report which can be shared with a physician. For those looking for feedback on their ECGs, GEMS™ Mobile provides access to CardioComm's SMART Monitoring ECG reading service for a professional review for the presence of a number of potential arrhythmias in under an hour. ECGs can also be connected directly to the GEMS™ WIN software allowing patients to be monitored directly by hospitals and healthcare professionals.
Unlike the US market, availability of personal ECG monitoring devices in Canada is limited due to ISO 13485 requirements that went into effect in 2019. Companies intending to sell medical devices into Canada must hold ISO 13485 certification in compliance with a more demanding Medical Device Single Audit Program ("MDSAP"). CardioComm completed its MDSAP certification in 2018 thereby solidifying the Company's abilities to produce and sell its GEMS™ software and act as a preferred importer, distributor and reseller of hospital and consumer ECG medical devices.
GEMS™ Mobile is available on Apple's App Store and on Google Play and is free with the purchase of a HeartCheck™ ECG device.
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).
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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