FDA Clears CardioComm Solutions’ GUAVA II ECG Viewer with ECG Acquisition, Analysis, Interpretation, and Reporting Capabili...
25 Février 2014 - 2:45PM
Access Wire
GUAVA II offers regulatory credibility and efficiency to ECG reading
services for physicians and hospitals
TORONTO, ONTARIO / ACCESSWIRE
/ CardioComm Solutions, Inc. (TSX VENTURE:EKG)
("CardioComm Solutions" or the "Company") a global medical provider of
electrocardiogram ("ECG") acquisition and management software
solutions, confirms U.S. Food and Drug Administration ("FDA")
clearance of its GUAVA II ECG viewer technology as a Class II
Medical Device.
GUAVA II is the
most recent ECG viewer software technology to enter the market and
one of several CardioComm Solutions products to be provided an FDA
clearance. It utilizes a modular (plug-in) based architecture
allowing new features such as automated ECG analysis and
interpretation algorithms, and ECG de-noising solutions to be
added. GUAVA II is to be used to acquire, store, retrieve, analyze
and produce measurements as well as textual interpretations, on ECG
recordings and ECG data from a variety of single and multi-lead ECG
devices.
CardioComm Solutions' software
is developed under strict ISO standards and international
regulations and must receive market clearances from regional
regulatory authorities prior to its sale. "Different rules are in
place to govern commercial ECG software engineering companies
versus ECG service companies with respect to software clearances
and enhancements. The FDA does not regulate software
designed and developed for internal use; accordingly, many
ECG independent diagnostic testing facilities
("IDTFs") do not use or maintain software under FDA
compliance. They also do not need regulatory market
clearance on software they have developed themselves for providing
their services. As a manufacturer, vendor and service
provider, CardioComm Solutions sets itself apart from
industry as a company that secures appropriate regulatory
clearances for the sale of its software internationally," stated
Jonathan Ward, President of AJW Technology
Consultants, Inc., regulatory agency for CardioComm
Solutions.
"GUAVA II, offers a new level
of regulatory credibility to ECG reading services,
opening new opportunities to physicians and hospitals that wish to
have ECG reviews completed that are adherent with all possible
medical clearances. Physicians reading ECGs for, and hospitals
receiving ECG reports generated from, ECG service providers may not
be aware that an ECG system is being relied upon that may hold no
current FDA clearance. GUAVA II will allow such service providers
the option to customize their ECG management systems with an FDA
compliant solution. GUAVA II will also offer significant data
development and interoperability potential, will serve to
streamline work flow, reduce staffing costs and
improve the efficiency of identifying potentially life threatening
arrhythmias in monitored patients," said Daniel Pawlik, VP Sales
and Marketing for the Company.
"In our GEMS(TM) and GC12 host
applications, GUAVA I is an integrated ECG viewer technology.
Utilizing GUAVA II's Application Programming Interface ("API"),
third party organizations and software developers may now license
GUAVA II to integrate its capabilities within their own products.
Adding this FDA cleared technology for the viewing, measure and
physician sign-off of acquired ECGs, a critical function of any ECG
service, would provide a market differentiator to any commercial
ECG service and medical call centre globally," said Etienne Grima,
Chief Executive Officer of CardioComm Solutions.
"Guava II is a
completely rewritten and re-architected replacement for Guava I. It
contains a re-implemented and expanded core, viewer, and plug-in
infrastructure which enable us to add support for new devices,
algorithms and additional biological signal measures.
Importantly, the layered architecture enables us to develop
native support and interfaces with mobile platforms
such as iOS and Android, and compatibility with browsers such as
IE, Chrome, Safari and Fire Fox, in the future," said Wade Barnes,
CTO of the Company.
"Developing and
integrating APIs within patient management
applications and across multiple platforms has been a
major issue in the healthcare space. Our release of GUAVA II is an
important step forward in addressing this need. We
also will incorporate automated interpretive algorithms and ECG
de-noising and auto triaging capabilities into GUAVA II which will
benefit the Company's GEMS(TM), GlobalCardio(TM) and HeartCheck(TM)
PEN ECG SMART Monitoring services, all of which shall set an
industry standard for high quality ECG service delivery," concluded
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
1-877-977-9425
investorrelations@cardiocommsolutions.com
www.cardiocommsolutions.com
Forward-looking statements
This release may contain
certain forward-looking statements and forward looking information
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. Such statements and information reflect
management's current beliefs and are based on information currently
available to management. By their nature,
forward-looking statements and forward-looking information 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 and forward-looking information.
In evaluating these
statements, readers should: specifically consider risks discussed
under the heading "Risk
Factors" in the Company's Annual Information Form,
available at www.sedar.com; not to place
undue reliance on forward-looking statements and forward-looking
information; be aware the Company does not assume any obligation to
update the forward-looking statements and forward-looking
information contained in this Annual Information Form other than as
required by applicable laws (including without limitation Section
5.8(2) of National Instrument 51-102 (Continuous Disclosure
Obligations).
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.
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