Editorial Contacts: CardioComm Solutions: Christel K. Hall,
APR CBC Etienne Grima, M.Sc. CHE
775-267-9232 416-977-8010 X227
christel@prowrite-pr.com egrima@cardiocommsolutions.com
Follows FDA Clearance for Over-the-Counter (OTC) Sales &
Marketing of the
Consumer-based, HeartCheck™ Pen Handheld ECG.
January 24, 2012 - - Toronto, Canada - - CardioComm Solutions, Inc. (CardioComm Solutions) received confirmation from the Canadian Medical Devices Conformity Assessment System (CMDCAS) that it had cleared an ISO audit performed by DQS Medizinprodukte GmbH. CardioComm Solutions is registered under Health Canada's Therapeutic Products Programme (TPP) according to ISO 13485:2003 and CMDCAS as well as MDD regulations, for the
'Manufacturing and Distribution of Health Management Software
Systems and Distribution of Health Monitoring Devices.' The
mission of the TPP, and the purpose of the audit, is to
ensure that drugs, medical devices, and other therapeutic
products available in Canada are safe, effective and of high
quality.
The audit reported that management review, resource planning
processes and corrective action loops "are very well
implemented" and that the design and development process is
"fully implemented and very well documented." In addition,
the following responsibilities were audited: Production and
Process Controls; Customer Related Processes; Implementation
of Applicable Canadian Medical Devices Regulations, Part 1
Requirements; Implementation of Regulatory Requirements of
the Directive 93/42/EEC; and Document Control
Processes.
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The audit concluded that the requirements of all applicable
ISO 13485:2003 standards as well as Canadian regulatory
requirements are fulfilled, that CardioComm Solutions'
quality system is well established and that no non-
conformities were found.
"This is excellent news for CardioComm Solutions", stated
Etienne Grima, CardioComm Solutions' CEO, "especially in
light of the rally in our stock price and brisk trading. The
recent market response provides a clear signal that our
shareholders and corporate partners understand the
significance of the FDA's permission for CardioComm Solutions
to sell the HeartCheck™ Pen with our GEMS™ Home software. The
results of this ISO audit demonstrates that what
differentiates CardioComm Solutions in the marketplace is our
design excellence and compliance pedigree as an
ISO-certified, FDA-compliant software engineering and
solutions company."
CardioComm Solutions achieved their first FDA clearance in
January 1999 and their GEMS™ software platform has been FDA
cleared as a Class II Medical Device since 2002.
"These 10-plus years operating in the highly regulated
medical software market has allowed us to become a trusted
and preferred provider in the prescribed ECG services
market," added Grima. "Our GEMSTM medical
customer base
includes Toronto-based St. Michael's Hospital and the
Hospital for Sick Children, the Ottawa Heart Institute, the
Calgary Foothills Hospital in Alberta, as well as
US-based clients such as the Mayo Clinic Health System
Hospitals and Kaiser
Permanente. Additionally, CardioComm Solutions has a customer
footprint covering more than 20 countries and has contractual
relationships with clients such as AstraZeneca, GE HealthCare
and the Philips Remote Cardiac Services."
CardioComm Solutions is now preparing for its move into the
consumer medical market. "Our target is to reach the 3C
market (Consumers with Chronic
2
Conditions)," explained Grima, "as well as those interested
in primary disease prevention. The HeartCheck™ PEN, together
with GEMS™ Home and our C4 medical call service will serve to
connect the 3C consumer to healthcare practitioners using a
solution that is globally expandable."
"The FDA clearance was a material announcement and marks the
first phase of the pre-launch plans for the HeartCheck™ PEN
distribution and sales. Passing the 2012 ISO Audit confirms
we are in excellent shape to proceed to next steps, which
will involve confirming sales channels and agency
representation across several global markets, finalizing
technology infrastructure for placement of multi- country C4
locations to honor the requirements to house medical data in
the country of service, and to confirm production timelines"
stated Grima. "We have been on a progressive and consistent
path and believe that this is CardioComm Solutions' time. It
is our 2012 goal to connect consumers' health in a way that
has never been done before - we are truly at the door step of
exciting innovation and service."
For more information on the Assessment Audit, the HeartCheck™ Pen or any CardioComm Solutions product or service, call the sales and marketing group at 1-877-977-9425 toll free in the U.S. and Canada, or email sales@cardiocommsolutions.com.
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