CardioComm Solutions' Heartcheck(TM) CardiBeat Handheld ECG Device Cleared by Health Canada for Direct-to-Consumer Sales
The Bluetooth HeartCheck(TM) CardiBeat and GEMS(TM) Mobile Smartphone App will Target Home, Outpatient, Telemedicine and Cardiac Arrhythmia Monitoring Markets
Toronto, Ontario--(Newsfile Corp. - May 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 received approval from Health Canada for the over-the-counter ("OTC") sales and marketing of its existing GEMS™ Mobile smartphone app and for the HeartCheck™ CardiBeat, its newest handheld heart rhythm monitor. Both devices were cleared by the Food and Drug Administration ("FDA") in early 2019.
The Company is very pleased with the rapid approval of the HeartCheck™ CardiBeat ECG monitor application, which was submitted to Health Canada on April 11, 2019. The GEMS™ Mobile Smartphone ECG app is cleared under pre-existing GEMS™ software approvals.
The Bluetooth-enabled and rechargeable CardiBeat easily enables anyone to take a medical-grade ECG recording by simply holding the device in both hands or by holding the device in the right hand and placing it against the left side of their chest. The GEMS™ Mobile app manages ECGs recorded by HeartCheck™ devices and provides near-real-time feedback through the generation of a free 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. This service provides a professional ECG review to confirm the presence or absence of a number of potential arrhythmias. CardioComm's ECG pricing is highly competitive compared to other service offerings, and includes a new pricing of U$S1.99 for an ECG Triage offered with a response time as rapid as 30 minutes. ECG connectivity is also possible directly to the Company's GEMS™ WIN software, which is used by 15 Canadian Hospitals allowing for the opportunity for patients to be monitored directly by physicians and healthcare professionals.
Unlike the US market, availability of personal ECG monitoring devices in Canada is limited, since companies intending to sell such devices must hold ISO certification in compliance with the more demanding Medical Device Single Audit Program ("MDSAP") requirements. CardioComm completed its MDSAP certification in 2018, thereby solidifying the Company's abilities to produce and sell its cardiac monitoring software and hardware innovations to consumers and to serve as a preferred importer, distributor and reseller of other manufacturers' hospital and ECG medical devices.
GEMS™ Mobile is available on Apple's App Store and on Google Play and is free with the purchase of a HeartCheckTM 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).
FOR FURTHER INFORMATION PLEASE CONTACT:
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.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/44687