The heartbeat of cardiovascular medicine and telemedicine

Patented systems enable medical professionals, patients, and other healthcare professionals, clinics, hospitals and call centres to access and manage patient information in a secure and reliable environment

Sponsored
AGORACOM NEWS FLASH

BREAKING: Spyder Cannabis Receives Approval on Development Permit for its Flagship Cannabis Store in Calgary, Alberta

  • Received approval on their development permit for a flagship retail location in the heart of Calgary
  • Spyder has now been accepted by Alberta Health Services and will begin construction in the coming weeks.
  • This brings Spyder’s total retail to 6 locations across Ontario and Alberta, this number is expected to grow over the coming months.

Spdr logo large

Hub On AGORACOM / Read Release

Message: CardioComm Solutions Sets the Record Straight; The First Company to Receive Approval for ECG Product Sales Direct to Consumers

CardioComm Solutions Sets the Record Straight; The First Company to Receive Approval for ECG Product Sales Direct to Consumers

posted on Sep 27, 2018 09:26AM

The 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 2012

Toronto, Ontario--(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 Rx and OTC health and wellness markets. From single lead to 12 lead ECG recordings, whether 30 seconds in duration or 30 days, regardless of the operating system or web browser used, CardioComm has heart monitoring solutions compatible with many manufacturers' hardware and client connectivity requirements.

CardioComm considers the entry of new ECG monitoring hardware manufacturers to the sector as an opportunity for collaboration and to further leverage CardioComm's software knowledge and credibility. The Company believes that new partnerships between CardioComm and new device manufacturers will provide consumers access to products with a trusted ECG monitoring software backend, providing new entrants with shorter development timeframes and quicker product acceptance by consumers, physicians and patient monitoring/telemedicine organizations.

To learn more about CardioComm's products and for further updates regarding HeartCheck™ ECG device integrations please visit the Company's websites at www.cardiocommsolutions.com and www.theheartcheck.com.
 
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
 
Etienne Grima, Chief Executive Officer
1-877-977-9425 x227
[email protected]

[email protected]

 
Forward-looking statements

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.

Share
New Message
Please login to post a reply