GUAVA II offers regulatory credibility and efficiency to ECG reading services for physicians and hospitals
TORONTO, ONTARIO – 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™ 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™, GlobalCardio™ and HeartCheck™ 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.
