TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE: EKG) (“CardioComm” or the “Company”), a leading global medical provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, confirms plans to develop a multi-lead, wireless, ECG patch device for use in clinics, skilled nursing facilities, clinical trials as well as to support remote patient monitoring (“RPM”) and telehealth services and prescribed in-home arrhythmia monitoring.
The wearable innovation is a result of a software/hardware partnership agreement with South Korea based Healthrian Co. Ltd. (“Healthrian”). The HeartCheck™ 12 lead/Holter/event ECG platform will include a compact, rechargeable and water proof ECG recorder, a self-placed disposable ECG patch with pre-alignment anatomical placement of electrodes, a smartphone mobile app and a HIPAA-compliant cloud-based ECG management solution that will support automated algorithm assisted, and manual reviews and reporting, of uploaded ECG recordings.
CardioComm has already implemented a family of ECG management systems that can support one to 12 leads of ECG data of varying durations that are licensed under the Global ECG Management Solution (“GEMS™” ) and GlobalCardio™ product brands with Health Canada and the Food and Drug Administration (“FDA”) Class II medical device clearances for the sale of over-the-counter and through prescription. Healthrian has developed a novel 12 lead ECG monitoring hardware solution using an ECG module that can connect via Bluetooth to a Smart device for the transfer of collected multi-channel ECG data. The module can use a number of different ECG electrode options including a patch or conventional ECG cables. Healthrian and CardioComm plan to integrate their respective technologies to bring multiple new medical and wellness devices to service the ambulatory ECG and arrhythmia monitoring markets globally.
CardioComm will be the lead applicant for medical device clearances with the FDA and Health Canada and will leverage their cleared GEMS™ and GlobalCardio™ software technologies, existing Medical Device Establishment Licenses and the Company’s ISO 13485:2016 MDSAP quality management system certification for both countries to streamline the application process.
Two phases of medical device applications are planned. The first phase will be eminent and will accommodate the wearable, wireless, ECG monitor in a standard configuration to record 12 lead ECGs for durations of a few seconds (resting) to a few days (ambulatory) using conventional lead sets with traditional disposable single ECG electrodes or alternatively using a disposable, multi-lead (12) ECG patch. The first phase will include integration with CardioComm’s existing medical device cleared software. The companies will continue development of their technologies with plans to release a configurable device with selectable inputs of one to 12 leads of data as a resting ECG monitor or as a Holter/event monitor for continuous and long term ECG monitoring (up to 30 days). The second phase will be associated with new CardioComm software medical device clearances for Holter with automated arrhythmia detection and classification technologies.
The Company confirms that software/device integration and compatibility testing has been completed.
To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations, please visit the Company’s websites at
www.cardiocommsolutions.com and www.theheartcheck.com.