CardioComm Solutions Inc. Receives CE Mark Approval for Heartcheck Handheld ECG Device Sales in Europe
Published: Dec 14, 2012
CE marking on a product is a declaration that CardioComm Solution’s product complies with the essential requirements of the relevant European health, safety and environmental protection legislation and allows the product to be legally placed within the European market and also ensures the free movement of the product within the European Free Trade Association Countries and the European Union, a single market comprised of 34 countries. CardioComm Solutions’ software associated with the HeartCheckTM products are approved under the Company’s pre-existing CE Mark.
“The audit and inspection process required to secure the CE Mark involved months of work and a full review of our Canadian based facilities. The audit was performed by DQS Medizinprodukte GmbH (Frankfurt, Germany). With the audits completed and CE Mark granted, CardioComm Solutions can now proceed with its overseas market development under the HeartCheckTM device brand in addition to its existing GEMSTM software brand. This will allow the Company to add new proprietary ECG and additional bio-monitoring device solutions as they become available,” said Mr Jon Ward, President and CEO, AJW Technology Consultants, Inc., PharmaMed Clinical, Inc., the Company’s regulatory representation.
“With the CE Mark now being granted, we can proceed to the next step of securing multi-country distributors for the sale of the PEN. Distributor qualifications have been ongoing since the early summer; however, most required the CE mark to be awarded under the HeartCheckTM/CardioComm Solutions brand to be able to proceed further,” said Simi Grosman, member of the CardioComm Solutions Board of Directors.
“Today’s CE announcement is a critical success milestone for CardioComm Solutions. CE approval for the sale and distribution of the HeartCheckTM PEN ECG, the HeartCheckTM ECG Monitor and our SMART Monitoring services solution, together with existing CE approvals for our Global ECG Solutions (GEMSTM) software, will now permit our entry into all European consumer, medical and prescribed health care markets,” said Etienne Grima, CEO of CardioComm Solutions. “To this point, we have expanded our advertizing efforts within HospiMedica International (English) and HospiMedica en Espanol (Spanish), which in combination with now having the CE mark granted, will support our recent Medica based marketing efforts where meetings were held with several European and Asian device manufacturer and distributor organizations. The Hopsimedica publications will have premium placement of CardioComm Solutions products and HeartCheckTM devices and will be seen by key hospital decision makers and medical equipment dealers/distributors in Europe, Latin America, the Middle East/Africa and Asia/Pacific. With FDA, Health Canada and European sales and marketing approvals secured we can now turn our attention to securing approvals in China and India”, closed Etienne Grima.
About CardioComm Solutions
CardioComm Solution’s 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, Inc. is headquartered in Toronto, Canada, with offices in Victoria, B.C.
FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
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.