FDA and Canadian Regulatory Approvals Secured for Sales of the
HeartCheckTM PEN and HeartCheckTM
ECG Monitor as Class II Medical Devices for Handheld ECG Monitoring
Under CardioComm Solutionsâ HeartCheckTM Brand.
Company Website:
http://www.theheartcheck.com/
TORONTO -- (Business Wire)
CardioComm Solutions, Inc. (TSX-V: EKG) (âCardioComm Solutionsâ or the
âCompanyâ), a global medical provider of electrocardiogram (âECGâ)
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 personâs home computer
also provides connectivity between the HeartCheckTM PEN
readings and CardioComm Solutionsâ ECG coordinating centre known as C4.
GEMSTM Home use is approved by Health Canada under the
Companyâs 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.
âI 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
Solutionsâ 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
todayâs fall in line with CardioComm Solutionsâ co-ordinated North
American launch strategy for sale of both the locked (unlockable) and
unlocked (ECG displaying) versions of the HeartCheckTM ECG
PEN services,â said Etienne Grima, CEO of the Company.
âWe 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 âconnected healthâ 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 todayâs news,â said Dr. Anatoly
Langer, Chairman of the Board of Directors for CardioComm Solutions.
âCardioComm Solutionsâ 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,â
said Etienne Grima.
âOur 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 Companyâs
product development schedule for 2012/2013 and we look forward to
expanding our cardiac communications solutions reputation into the arena
of biometric communications solutions,â 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 Solutionsâ 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.
www.cardiocommsolutions.com
Forward-looking statements
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.
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.
Contacts:
Cardiocomm Solutions
Etienne Grima, Chief Executive Officer
1-877-977-9425
investorrelations@cardiocommsolutions.com
Source: Cardiocomm Solutions, Inc.
© 2024 Canjex Publishing Ltd. All rights reserved.