CardioComm Solutions, Inc. engages in the development of software for the cardiology field worldwide. Its technology is used in products for recording, viewing, analyzing, and storing ECGs for the diagnosis and management of cardiac patients. The company's products include Global ECG Management System, a software solution for cardiac event monitoring; GlobalCardio 3 Lead; GlobalCardio 12 Lead, a Web enabled portable ECG device that is EMR compatible; ECG Viewer SDK; HeartCheck, a handheld ECG monitor; QRS 12 Lead; cardiac science atria ECG recorder; DR200/HE, a holter and event recorder; Burdick Atria 3100 ECG, an electrocardiogram system for private practices; Burdick Atria 6100 ECG, a portable ECG/EKG system for hospitals and cardiology clinics; and GEMSTrak AF, a cardiac event recorder with atrial fibrillation auto-capture. It also offers GEMS Air, a live wireless ECG monitoring solution; AutoAttendant, which allows healthcare providers to focus on providing patient care; GEMS HL7 and EMR Interface that allows patient and follow-up information to be sent in an HL7 message format, to other EMR systems that are HL7 compliant; and C4 coordinating centre for cardiac event loop monitoring services. The company sells its products to hospitals, call centers, and physician's offices through a combination of its external distribution network and sales team. CardioComm Solutions, Inc. was incorporated in 1989 and is headquartered in Toronto, Canada. http://www.cardiocommsolutions.com/handheld/index.html
Editorial Contacts: CardioComm Solutions:
Christel K. Hall, APR CBC Etienne Grima, M.Sc. CHE
775-267-9232 416-977-8010 X227 [email protected] [email protected]
CardioComm Solutions, Inc. Receives FDA Clearance to
Market First Over-the-Counter Heart Monitoring Solution
Firm Has Exclusive International Distribution of HeartCheck™ Pen &
Associated GEMS Home Software
Toronto, Canada - - January 19, 2012 - - CardioComm Solutions, Inc.
(TSX-V: EKG), 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 Solutionsʼ 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 Solutionsʼ C4 medical call service telemedicine
group for review by a physician.
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 Solutionʼs
C4 medical call centre.
"Through this consumer product," said Etienne Grima, CardioComm
Solutionsʼ CEO, "we are truly putting peopleʼs 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 Penʼs 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
"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
"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 email [email protected]
About CardioComm Solutions, Inc.
CardioCommʼs 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 Americanbased
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, B.C. http://www.cardiocommsolutions.com/press/2012/January%2019,%202012.pdf