TORONTO--()--CardioComm Solutions, Inc. (TSX-V: EKG) (“CardioComm Solutions” or the “Company”), a global medical provider of electrocardiogram (“ECG”) acquisition and management software solutions, has submitted an application with the U.S. Food and Drug Administration (“FDA”) for clearance of its GUAVATM II ECG viewer technology.
“We believe GUAVATM will continue to be one of the most sought after ECG viewers in our market. Given its ease of use, efficient editing tools and customizable features and with the enhancements scheduled with an FDA clearance, GUAVATM II will continue to be the favoured solution in the industry”
GUAVATM is a medical software device with a formal Application Programming Interface (API). As an API, it can be incorporated and invoked from Host Applications to provide services for capturing, storing, retrieving, viewing, editing, and analyzing electrocardiograms (“ECGs”) (1-, 2-, 3-Channel and 12-Lead).
“In current versions of our host applications of GEMSTM and GlobalCardioTM ECG management software solutions, GUAVATM is an embedded ECG viewer technology. Where companies have their own information management and work flow solutions and do not require GEMSTM or GlobalCardioTM, we instead have provided customized licenses of this ECG viewer. This is the case seen with large organizations running commercial medical call centres,” said Etienne Grima, CEO of CardioComm Solutions.
“GUAVATM II will be released as a standalone Class II Medical Device solution that will offer new advantages over the current version. GUAVATM II will provide automated ECG triaging capabilities which are highly relevant for high volume wireless ECG transmissions and will specifically target the mobile (GMS) cardiac telemetry market in United States. The incorporation of two automated algorithms will enable triaging capabilities that will streamline work flow, reduce staffing costs especially for high volume ECG call centres and improve the efficiency of identifying potentially life threatening arrhythmias in monitored patients,” added Etienne Grima.
GUAVATM II will analyze and produce measurements of the ECG recording as well as textual interpretations. The product will also include an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis for QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of captured data. GUAVATM II is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices.
As an API, GUAVATM II may also be licensed to 3rd party organizations and other software developers interested in embedding the capabilities within their own products. “We believe GUAVATM will continue to be one of the most sought after ECG viewers in our market. Given its ease of use, efficient editing tools and customizable features and with the enhancements scheduled with an FDA clearance, GUAVATM II will continue to be the favoured solution in the industry,” said Mona Palfreyman, Director of Quality Assurance and Customer Support of CardioComm Solutions.
“The commercial opportunities do not stop with the traditional medical monitoring market. Rather, this technology will have a place in further enhancing and automating our consumer based SMART Monitoring solution, a technologist and physician manned service used to support the recently launched HeartCheckTM PEN product. Once we receive the FDA market clearance for GUAVATM II, this software application will then serve as a platform for future 510(k) submissions as we introduce new biosignal analyses which, in turn, will support our expanding product portfolio and marketing plans for 2013,” added Mr. Grima.
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, Canada, with offices in Victoria, British Columbia, Canada.
This release may contain certain forward-looking statements 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. By their nature, forward-looking statements 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.
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