Clearance opens the way for HeartCheck(TM) Device Sales and SMART Monitoring ECG Services in China
TORONTO, ONTARIO / ACCESSWIRE / May 14 2014 / CardioComm Solutions, Inc. (TSX VENTURE:EKG) ("CardioComm Solutions" or the "Company"), a global medical provider of electrocardiogram ("ECG") acquisition and management software solutions, confirms that China's Food and Drug Administration ("CFDA") has cleared the HeartCheck(TM) PEN ECG device and GEMS(TM) Home software for sale in China.
CardioComm Solutions had already secured clearances for the sale of the HeartCheck(TM) PEN through the US FDA, Health Canada and by European CE marking. GEMS(TM) Home, the associated Windows-based software that provides a personal electronic ECG health record management solution, also enables access to the Company's global SMART Monitoring ECG reading service. The CFDA clearance was secured by Beijing Choice Electronic Technology Co., Ltd. ("BCET"), which manufactures the HeartCheck(TM) PEN exclusively for CardioComm Solutions under the BCET original equipment manufacturer's code MD100P. The CFDA clearance also specifically names GEMS(TM) Home. With CFDA clearance, registration of the HeartCheck(TM) brand can be completed in preparation for the sale of the devices and the start of ECG reading services through GEMSTM Home in China.
The CFDA clearance of the HeartCheck(TM) PEN and SMART Monitoring ECG service provide CardioComm Solutions with access to another significant market. The CFDA applications were managed by BCET with assistance from CardioComm Solutions for preparation of the GEMS(TM) Home components. The Company's next step is registration of the HeartCheck(TM) brand name fusing the MD100P clearance, similar to what has been completed in Europe and North America. In order to sell the devices and offer ECG reading services, CardioComm Solutions will release a Mandarin language version of GEMS(TM) Home and SMART Monitoring ECG interpretation reports.
"We are pleased to have the access to sell our devices and ECG services into China. In anticipation of this CFDA clearance, BCET and CardioComm Solutions have been planning the launch of a national HeartCheck(TM) and SMART Monitoring ECG screening service that would utilize the many community clinics for private as well as government reimbursed SMART Monitoring ECG reading referrals," said Etienne Grima, CEO of CardioComm Solutions. "A high level of control by the Company is important for appropriate access and use of our SMART Monitoring ECG service. By implementing a pre-authorized, unique serial number registration procedure through GEMSTM Home, the gate keeper for accessing SMART Monitoring, we can ensure that only HeartCheck(TM) devices manufactured for us will work with both GEMS(TM) Home and the SMART Monitoring service."
"CardioComm Solutions already utilizes a SunGard availability service for the SMART Monitoring infrastructure which can be scaled to support SMART Monitoring in any of 16 locations internationally. We intend to expand into China through our trusted partners where the sheer size of the potential market will allow us to realize new revenue streams from activation of HeartCheck(TM) devices on the SMART Monitoring ECG service, as well as from a share of per ECG fees that will be charged for use of the ECG service," said Simi Grosman, member of the Board of Directors for CardioComm Solutions.
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, Ontario, Canada, with offices in Victoria, B.C.
FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
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SOURCE: CardioComm Solutions, Inc.