FDA Clears CardioComm Solutions’ GUAVA II ECG Viewer with ECG Acquisition, Analysis, Interpretation, and Reporting Capabilities as a Class II Medical Deviceadmin
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
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.
Posted: February 25th, 2014 under ACCESSWIRE.