Business
CardioComm Solutions Files with Health Canada for Direct to Consumer Sales Approval of the Heartcheck(TM) Cardibeat Handheld ECG Device
Toronto, Ontario--(Newsfile Corp. - April 9, 2019) - CardioComm Solutions, Inc. (TSXV: EKG) ...
About this update from Cardiocomm Solutions, Inc.
[{"type":"text","content":"CardioComm Solutions Files with Health Canada for Direct to Consumer Sales Approval of the Heartcheck(TM) Cardibeat Handheld ECG DeviceBluetooth Connected HeartCheck CardiBeat and GEMS Mobile Smartphone App to Target Underserviced Canadian Home and Telemedicine Arrhythmia Monitoring MarketsToronto, 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 ...