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, 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. GEMS™ 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 visit the Company’s websites at www.cardiocommsolutions.com and www.theheartcheck.com.
