TORONTO--()--CardioComm Solutions, Inc. (TSX-V: EKG) (“CardioComm Solutions” or the “Company”), a global medical provider of electrocardiogram (“ECG”) acquisition and management software solutions, has received clearance from Health Canada for the sales and marketing of their HeartCheckTM ECG PEN to both consumers and patients under physician prescription.
The Health Canada license (89624) was granted September 6, 2012. The HeartCheck™ ECG PEN was first cleared for sale in the United States by the FDA (K111159) as the HeartCheckTM PEN Handheld ECG with GEMSTM Home. The Health Canada approval now completes the ability for CardioComm Solutions to market their HeartCheckTM brand of handheld ECG devices across North America. GEMSTM Home, the free downloadable, software designed by the Company to provide a personal heart rhythm/ECG health record on a person’s home computer also provides connectivity between the HeartCheckTM PEN readings and CardioComm Solutions’ ECG coordinating centre known as C4. GEMSTM Home use is approved by Health Canada under the Company’s existing GlobalCardioTM and GEMSTM clearances.
The initial application to secure a Health Canada approval for a new medical device license for a private label medical device product was made July 23, 2012 for the prescription version of the HeartCheckTM PEN. The Company recently completed language translation to meet Health Canada requirements for consumer product sales through the assistance of Lionbridge Technologies Inc., a global leading provider of translation, development and testing solutions, and we were able to modify the original Health Canada application to include the OTC version of the HeartCheckTM PEN.
“I believe that securing two regulatory clearances from the FDA and three new Health Canada medical licenses within a ten month period highlights our commitment to quality and points directly to CardioComm Solutions’ strength as a leader in cardiac communications. All clearances were secured with only a short delay from the date of submission, with this final pair occurring in less than two months and today’s fall in line with CardioComm Solutions’ co-ordinated North American launch strategy for sale of both the locked (unlockable) and unlocked (ECG displaying) versions of the HeartCheckTM ECG PEN services,” said Etienne Grima, CEO of the Company.
“We are very pleased with the news of these final approvals and acknowledge the efforts of our staff in both the Toronto (Ontario) and Victoria (British Columbia) offices. We have gone on record stating that CardioComm Solutions is committed to establishing a successful and innovative line of ‘connected health’ products to enable consumers and patients to put their heart health into their own hands and enable easier and more cost effective telemedicine and remote monitoring solutions for prescribed services as well as for self monitoring initiatives. I could not be more encouraged to believe in the achievement of this goal after seeing today’s news,” said Dr. Anatoly Langer, Chairman of the Board of Directors for CardioComm Solutions.
“CardioComm Solutions’ strength is our software solutions. We are a cardiac communications solutions company and we ensure ECG recording device integration with our GEMSTM and GlobalCardioTM products is complete. This is the case whether it is for 12 lead ECG devices, event loop recorders or handheld consumer based ECG devices for use in clinic or under remote monitoring and telemedicine applications,” said Etienne Grima.
“Our plans remain on track for the North American launch of the HeartCheckTM PEN and SMART Monitoring service, as well as for the development of a global distribution network. Expansion into multiple biometric monitoring markets is also within the Company’s product development schedule for 2012/2013 and we look forward to expanding our cardiac communications solutions reputation into the arena of biometric communications solutions,” added Mr. Simi Grosman, member of the Board of Directors for CardioComm Solutions.
For more information on the HeartCheckTM brand of products and associated remote and home based ECG services, please go to www.theheartcheck.com.
About CardioComm Solutions
CardioComm Solutions’ patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms (ECGs) 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. The Company has earned the ISO 13485 certification, is HPB approved, HIPAA compliant, and has received FDA market clearance for its software devices. CardioComm Solutions is headquartered in Toronto, Canada, with offices in Victoria, British Columbia, Canada.
This release may contain certain forward-looking statements 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. By their nature, forward-looking statements 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.
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