CardioComm Solutions Secures Health Canada Clearance for Artificial Intelligence ECG Interpretation for Multiple Cardiac Arrhythmias

Rhea-AI Summary

CardioComm Solutions, Inc. (TSXV: EKG) has received Health Canada clearance for its GEMS™ Rhythm ECG artificial intelligence (AI) software for automated detection of multiple arrhythmias and morphology abnormalities. The software will detect conditions such as atrial fibrillation, prolonged QT intervals, tachycardia, bradycardia, and more. This clearance is a critical milestone in developing GEMS™ into an all-in-one, device-agnostic ECG software solution.

GEMS™ Rhythm will be initially offered with GEMS™ FLEX ECG software for analyzing ECG data from event recorders worn up to 30 days. Future releases will include integration with GEMS™ Holter and GEMS™ LTCM solutions for continuous monitoring over 24 hours to 14 days. The NRC Industrial Research Assistance Program provided partial funding support of up to $150,000 for this project.

Positive

• Received Health Canada clearance for GEMS™ Rhythm ECG AI software
• Software capable of detecting multiple arrhythmias and morphology abnormalities
• Critical milestone in developing an all-in-one, device-agnostic ECG software solution
• Expanding product line to include Event, Holter/Event, and LTCM solutions
• Received up to $150,000 in research and development support from NRC-IRAP

Negative

• None.

GEMS(TM) Rhythm AI Clearance will Address Event, Holter and Long-Term Continuous ECG Monitoring Needs for Remote Patient Monitoring in Canada

Toronto, Ontario--(Newsfile Corp. - September 30, 2024) - CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a global medical provider of consumer heart monitoring and medical electrocardiogram ("ECG") software and hardware solutions, is pleased to announce it has received Health Canada clearance of its GEMS™ Rhythm ECG artificial intelligence (AI) software for the automated detection of multiple arrhythmias and morphology abnormalities.

The GEMS Rhythm arrhythmia and morphology abnormality AI detection will include atrial fibrillation, prolonged QT and QTc intervals, tachycardia/bradycardia/pause, average heart rate, PQ and QRS intervals, identification of patterns of different heart beats such as PACs, PVCs, bigeminy and trigemini, as well as estimation of the heart rate variability.

The clearance of the GEMS™ Rhythm technology is a critical milestone in the Company's product road map to develop its GEMS™ software into an all-in-one, device-agnostic, ECG software solution. GEMS™ Rhythm will first be offered with the Company's GEMS™ FLEX ECG software to support automated analysis of one to three leads of ECG data acquired through event recorders worn for up to 30 days. Additionally, GEMS™ Rhythm will automatically review ECGs from its consumer HeartCheck™ ECG products.

In the next phases of software releases, GEMS™ Rhythm will be used with the GEMS™ Holter and GEMS™ LTCM solutions (in development) to perform continuous monitoring of ECGs over durations of 24 hours to 14 days, with near real-time event triggering throughout the monitoring period. CardioComm's all-in-one GEMS™ solutions for Event, Holter/Event, and LTCM will provide hospitals, physician groups, and commercial laboratories with ultimate flexibility to provide customized patient care in a fully integrated, device-agnostic software solution.

GEMS™ Rhythm, GEMS Holter, and GEMS™ LTCM will join CardioComm's growing product lines, including the HeartCheck^TM branded home ECG devices and the Body-by-GEMS^TM multiple bio-signal monitoring solutions.

CardioComm is pleased to confirm that research and development support for this GEMS™ Rhythm project was provided in part through an NRC Industrial Research Assistance Program (NRC-IRAP) contribution agreement of up to $150,000.

To learn more about CardioComm's products and for further updates please visit the Company's website at www.cardiocommsolutions.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 and ISO 27001 certifications, is HIPAA compliant and holds medical device clearances and sales licenses from the USA (FDA) and Canada (Health Canada).

FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
1-877-977-9425 x227
investor.relations@cardiocommsolutions.com

Forward-looking statements

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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/225191

FAQ

What did CardioComm Solutions (TSXV: EKGGF) receive Health Canada clearance for?

CardioComm Solutions received Health Canada clearance for its GEMS™ Rhythm ECG artificial intelligence (AI) software for the automated detection of multiple arrhythmias and morphology abnormalities.

What conditions can the GEMS™ Rhythm AI software detect?

The GEMS™ Rhythm AI software can detect atrial fibrillation, prolonged QT and QTc intervals, tachycardia, bradycardia, pause, average heart rate, PQ and QRS intervals, PACs, PVCs, bigeminy, trigemini, and estimate heart rate variability.

How will CardioComm Solutions (TSXV: EKGGF) initially offer the GEMS™ Rhythm software?

CardioComm Solutions will initially offer GEMS™ Rhythm with their GEMS™ FLEX ECG software to support automated analysis of one to three leads of ECG data acquired through event recorders worn for up to 30 days.

What future developments are planned for the GEMS™ Rhythm software by CardioComm Solutions (TSXV: EKGGF)?

CardioComm Solutions plans to integrate GEMS™ Rhythm with GEMS™ Holter and GEMS™ LTCM solutions for continuous monitoring of ECGs over durations of 24 hours to 14 days, with near real-time event triggering.