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CardioComm Solutions Sets the Record Straight; The First Company to Receive Approval for ECG Product Sales Direct to Consumers
Toronto, Ontario--(Newsfile Corp. - September 27, 2018) - CardioComm Solutions, Inc. (TSXV: ...
About this update from Cardiocomm Solutions, Inc.
[{"type":"text","content":"CardioComm Solutions Sets the Record Straight; The First Company to Receive Approval for ECG Product Sales Direct to ConsumersThe HeartCheck(TM) ECG Pen and GEMS(TM) Home Were the First ECG Products Cleared for Direct to Consumer Sales in the USA and Canada in 2012Toronto, Ontario--(Newsfile Corp. - September 27, 2018) - 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, firmly responds to recent technology companies' announcements that it was the first company to be approved to sell an ECG product directly to consumers over the counter (\"OTC\") in North America. CardioComm was the first company to be approved to sell an ECG product directly to consumers in North America as evidenced by OTC Class II medical device clearances by both the United States Food and Drug Adminstration {\"FDA\") and Health Canada in 2012. There were no predicate OTC ECG devices at the time, which makes CardioComm a technology pioneer. The HeartCheck ECG PEN is currently available for OTC sales on the shelves of Canadian pharmacy chain Shoppers Drug Mart.CardioComm received a total of four Class II medical device approvals in 2012 from the FDA and Health Canada for its handheld HeartCheck ECG PEN and GEMS Home application, which manages ECGs from the device and produces ECG PDF reports. As a referred \"software as a medical device\" solutions provider, CardioComm received its first medical device clearances from the FDA and Health Canada for its hospital-based ambulatory (out patient) ECG management software back in 1998.In light of the recent claims cited, the Company is issuing this press release for the benefit of its investors, shareholders, business partners and consumers to remind all stakeholders of CardioComm's significant role in advancing the use of personalized ECG monitoring. Since its pioneering efforts in 2012, CardioComm has supported device manufacturers, ECG monitoring telemedicine platforms and research groups to bring new ECG monitoring technologies, automated interpretative algorithms and devices to market.As new hardware and software releases near commercial release under the Heartcheck and GEMS Mobile brand, CardioComm is well positioned to assume a larger share of the R...