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, confirms it has filed an application with the USA Food and Drug Administration (“FDA”) for premarket notification 510(k), Class II medical device clearance of the Company’s newest HeartCheck™ branded, handheld heart rhythm monitor.
The CardioComm device will be named the HeartCheck™ Cardi Beat and will also be marketed as the HeartCheck™ Beat. The Bluetooth enabled and rechargeable handheld device will allow a medical grade ECG recording to be taken in two different ways. Unlike commonly prescribed devices that only let the user take an ECG by holding the device in both hands (a Lead I ECG recording) the HeartCheck™ Beat will also offer users the added clinical advantage of taking a Lead II ECG by holding the device in the right hand and against the left side of the chest. Lead II measurements are more accurate for recording and diagnosing serious arrhythmias that start in the atrium such as atrial fibrillation and atrial flutter. This represents a significant diagnostic advantage over other currently available devices.
CardioComm has been very selective in the placement of its brand on ECG recording devices for sale into over-the-counter consumer and prescription-patient markets. Any devices that carries the HeartCheck™ brand has to pass stringent ISO 13485:2016 compliant product development and compatibility testing and provide hospital grade ECG recordings.
The FDA premarket notification 510(k) application included CardioComm’s iOS/Android compatible GEMS™ Mobile App. GEMS™ Mobile is based directly on the Company’s Global ECG Management Solutions (GEMS™) software which holds Class II Software as a medical device clearance and used by hospitals, physician groups and commercial ECG reading services throughout Canada and the USA for outpatient, ambulatory and remote ECG monitoring service. Not only is GEMS™ Mobile already an FDA cleared App, but just like its big brother hospital software GEMS™, it will also have compatibility with a number of different wireless ECG recording devices, including the option to support wireless 12 lead devices.
GEMS™ Mobile allows smart devices to receive ECG’s from HeartCheck™ devices for post-event or real-time/continuous cardiac monitoring. GEMS™ Mobile saves recorded ECG’s and transfers them to the Company’s cloud-based SMART Monitoring ECG reading service when convenient or as required. Once uploaded, ECG files can be reviewed and reported by physicians and feedback provided to the consumer, or patient, based on the ECG review findings. The process for unlocking, viewing and printing the ECG waveform will follow that of the Company’s FDA cleared HeartCheck™ ECG PEN and GEMS™ Home software. The consumer version of the GEMS™ Mobile App will be available for download on Apple’s App Store and on Google Play.
What is next for CardioComm? CEO Etienne Grima confirms that in addition to the pending release of additional HeartCheck™ branded devices, a physician version of GEMS™ Mobile will soon be available. This release, named GEMS™ Mobile Rx, will allow health care professionals to review ECGs right on a mobile device with ECG tools, allowing immediate and accurate complex calculations such as QT interval, QRS and PR durations to be made. The Company is planning for a release of the GEMS™ Mobile Rx soon after approval of the HeartCheck™ Cardi Beat.
Pricing of the HeartCheck™ Cardi Beat and the GEMS™ Mobile App will be disclosed once the FDA application process has been completed and the device approved for sale. To learn more about CardioComm’s products and for further updates regarding HeartCheck™ ECG device integrations please see the Company’s websites at www.cardiocommsolutions.com and www.theheartcheck.com
