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 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.
To learn more about CardioComm’s products please see the Company’s websites at
www.cardiocommsolutions.com and www.theheartcheck.com.
