WIRE)–CardioComm Solutions, Inc., a global medical provider of
ECG acquisition and management software solutions, received clearance from the
Food and Drug Administration (FDA) for over-the-counter (OTC) sales and
marketing of their consumer-based, hand-held heart rhythm monitor known as the
HeartCheck™ Pen Handheld ECG.
The FDA clearance also included CardioComm Solutions GEMS™
(Global ECG Management System) Home software, which enables the HeartCheck™ Pen
to be connected to a personal computer to upload the heart rhythm recording to
CardioComm Solutions C4 medical call service telemedicine group for review by
The HeartCheck™ Pen and GEMS™ Home solution provide an
extension to the HeartCheck™ ECG Monitor solution, which may be used only under
physician direction. Both devices can communicate with CardioComm Solutions C4
medical call centre.
“Through this consumer product,” said Etienne Grima,
CardioComm Solutions CEO, “we are truly putting peoples heart health into
their own hands.” The Pen will display only the heart rate count until an
interaction with a physician occurs. Once a C4 physician has provided review
and feedback to the customer, the Pens screen can be unlocked to display the
real-time ECG and heart rate count for subsequent heart rhythm recordings.
“We feel the HeartCheck™ Pen is a true remote monitoring
device because it is compact, easy to use, and takes accurate heart readings in
only 30 seconds. The Pen may be used from anywhere, including at home, the
office, the gym or in remote areas which are often inaccessible to common ECG
machines,” said Grima.
The HeartCheck™ Pen stores up to 20 ECGs, and its data can
be downloaded to GEMS™ Home, where repeated recordings can be managed in a
personal health data record. The GEMS™ Home software offers a simple software
user interface for managing heart rhythm recordings and associated data.
“What makes this product unique,” explained Grima, “is that
after a consumer sends a selected heart rate recording to the C4 medical call
center over the internet using GEMS Home, the actual ECG recording will be
reviewed and interpreted by an attending C4 physician. The ECG report will then
be made available to the customer, again through GEMS™ Home, where they may
retrieve the ECG interpretation and use it in communicating with their own
health care providers.”
“Any person interested in monitoring their health for
primary or secondary disease reasons would benefit from this solution,” stated
Michael Baber, Business Development Director for the HeartCheck™ brand.
CardioComm Solutions is now in the process of developing market channels for
the distribution of this new device and service.
“Our cycle time for bringing this product to its current
market-ready stage has been less than 14 months, and we intend to keep the
momentum going,” reported Grima. Dr. Anatoly Langer, Chairman of the Board for
CardioComm Solutions confirms, “As a cardiologist, I believe this development
represents the cutting edge of the intersection between medicine and
technology. Informed consumers who wish to have the freedom and the security of
monitoring their health will welcome being connected when they wish to access
the expertise that comes with our leading ECG management software GEMS.”
“A priority for the current year is the global
commercialization of the HeartCheck™ Pen Handheld ECG Monitor and GEMS™ Home
solution,” stated Grima. “In association with the launch of this new offering,
we are preparing for a financing round with an eye toward private placement.
Together with the anticipated completion of our new GEMS™ 4.0 platform, 2012
indeed promises to be an exciting time for CardioComm Solutions.”
For more information on 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
About CardioComm Solutions, Inc.
CardioComms 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
CardioComm Solutions, Inc. is headquartered in Toronto, Canada,
with offices in Victoria,