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Message: CardioComm Solutions Prepares New FDA Applications for Direct-to-Consumer and Physician Use Cardiac Arrhythmia Algorhythms
Apps for Automated Atrial Fibrillation and Prolonged QT Interval Detection will be Included in the Scope of Detection Options
Toronto, Ontario - (March 5, 2019) - CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a global provider of consumer heart monitoring and electrocardiogram ("ECG") acquisition and management software solutions, is preparing US Food and Drug Administration ("FDA") 510(k) Class II medical device clearance applications for new arrhythmia detection algorithms.
The main application will be for GEMS™ Rhythm, a full suite of arrhythmia detection tools designed for use with GEMS™ WIN, which is licensed to hospitals, clinics and commercial ECG scanning services. GEMS™ Rhythm will support long-term, continuous recordings of ECGs that are associated with new and higher paying reimbursement codes in Canada and the US. GEMS™ Rhythm will also be capable of running on smartphones, removing the dependence on access to cloud-based systems for the collection and interpretation of ECG data.
The Company will also seek approvals for GEMS™ Rhythm AF and GEMS™ Rhythm QT for consumer and prescription use. These auto-detection algorithms will be available as add-on features to the recently FDA- cleared GEMS™ Mobile app, the only iOS and Android smartphone ECG app that can connect to different manufacturers' ECG monitoring devices. GEMSTM Mobile with Rhythm AF will compete against solutions from AliveCor, Apple and others.
GEMS™ Rhythm QT would be the first QT interval prolongation screening solution released for smartphone use. QT interval abnormalities have been associated with sudden cardiac death sometimes seen in athletes and in patients prescribed certain medications. These abnormalities are better detected by devices like CardioComm's HeartCheck™ ECG PEN and HeartCheck™ CardiBeat, both of which allow a lead II ECG trace to be recorded.
The ability for GEMS™ Mobile to link consumer use of ECG devices to hospitals where GEMS™ WIN is licensed extends the patient monitoring experience beyond the fixed and short-term use of traditional, large and expensive ECG monitoring devices. This should lead to better patient care outcomes and open additional billing code revenue-generating opportunities for health care organizations.
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.
About CardioComm Solutions
CardioComm Solutions' patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms 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. CardioComm Solutions has earned the ISO 13485 certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).
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This release may contain certain forward-looking statements and forward-looking information 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. Such statements and information reflect management's current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information 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 and forward-looking information.
In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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