TORONTO, ONTARIO – CardioComm Solutions, Inc. (“CardioComm” or the “Company”) (TSX VENTURE:EKG) a leading global provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, has initiated the application process to the USA Food and Drug Administration (“FDA”) for premarket notification 510(K), Class II medical device clearance of the Company’s newest consumer-based and HeartCheck™ branded, hand-held heart rhythm monitor.
Preparations for the FDA pre-market notification application follows 16 months of stringent ISO 13485:2016 compliant product development and compatibility testing of this and several other Bluetooth ECG devices with CardioComm’s GEMS™ (Global ECG Management System) Win and GlobalCardio™ ECG management software platforms. The HeartCheck™ branded device name will be disclosed following submission of the FDA application, which will happen within the month of May. The Company expects to announce the progress on the release of other devices to the market as compliance testing is completed.
The FDA premarket notification 510(K) application will also include CardioComm’s downloadable GEMS™ Mobile App. The Company has confirmed that GEMS™ Mobile enables any HeartCheck™ branded or HeartCheck™ compatible Bluetooth device to be connected to iOS and Android Smart devices. The GEMS™ Mobile App will be available for download on Apple’s iTunes and on Google Play.
The GEMS™ Mobile App has been designed by CardioComm and is based directly on the Company’s already FDA cleared and Health Canada approved GEMS™ software. GEMS™ Mobile allows ECG’s to be transmitted to Smart devices for post-event or real-time/continuous cardiac monitoring following which GEMS™ Mobile will save the recorded ECG’s and transfer them to the Company’s cloud-based SMART Monitoring ECG reading service when convenient or as required. Once uploaded, ECGs can be reviewed and reported by physicians and feedback provided to the consumer, or patient, based on the ECG review findings. The workflow for unlocking and viewing the ECG waveform following physician review will follow that of the Company’s FDA cleared HeartCheck™ ECG PEN and GEMS™ Home software.
CardioComm is the first company in Canada and the USA to have received Class II medical device clearances for personal ECG monitoring devices under an OTC clearance. Since then several competitor products have come to market using CardioComm’s FDA approved device as the predicate technology for gaining their approvals. Imitated but not replicated, CardioComm’s differentiator is its 20 years of experience as a trusted ECG management and device connectivity solutions provider to the medical industry. With over one hundred customers from the medical markets licensing software from CardioComm’s family of GEMS™ technologies, CardioComm represents a medical company that brings credible and reliable health monitoring solutions to the consumer markets, versus companies that have developed as consumer device providers who are now trying to move into the medical space.
An FDA premarket notification 510(K) Class II medical device clearance for prescription sales is also being sought for the new HeartCheck™ device. Class II medical device clearances for Canadian and European Union markets will be sought in Q4 2018.
The Company confirms that it will continue to emphasize its recognized leadership as a software innovator in providing high impact medical software engineering solutions while working to broaden consumer access to a larger range of wireless, easy-to-use and innovative consumer and medical-wellness products. The introduction of device and software interpretive algorithms is also a priority for the Company as this will support its plans to soon bring other credible and affordable wearable and handheld, single and multi-lead ECG devices to the OTC and Rx markets, including some devices with multiple vital signs monitoring capabilities.
To learn more about the CardioComm’ products and for further updates regarding HeartCheck™ ECG device integrations please see the Company’s websites at www.cardiocommsolutions.com and www.theheartcheck.com
