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Wednesday, May 22, 2024

CARDIOCOMM SOLUTIONS: Leveraging Cutting-Edge Tech to Secure the Most Precious Rhythm of Life

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).

The best rhythm never stops beating and thrives on good health. With each momentary ebb and flow, the world is always tuned to the timeliest yet precarious rhythm. Heartbeat – the rhythm of life. However, for some, the tempo can drop or pick up in the blink of an eye. It’s known as ‘Arrhythmia’ – a severe heart disease that affects the heart rate or the rhythm.

The traditional set of ECG monitoring software fails miserably to track and monitor cardiac patients outside the hospital setting. Furthermore, with digital seeping into the daily lives, modern patients are well-informed and vouch for self-care models. So, providing mobile monitoring capabilities and unfettered access to patient data is crucial to the successful diagnosis of arrhythmias and the management of cardiac patients outside of the hospital environment. Located in Ontario, Canada, CardioComm has been pioneering the development of proprietary and specialized ECG software. “In 2012, CardioComm became North America’s first company to earn FDA and Health Canada OTC clearances. This gave us an economic immunity to sell manufacturing, marketing, and selling of ECG devices direct to consumers without the need of a physician’s prescription,” begins Etienne Grima, CEO, CardioComm.

Detecting arrhythmias has traditionally required the use of expensive ECG monitors only obtainable after seeing a physician or a visit to a hospital. In 2019, CardioComm received medical device clearances for a smartphone app. It enabled them to integrate the app with multiple brands of small, Bluetooth-enabled, and easy to use ECG monitors for the monitoring and diagnosis of a variety of arrhythmias. CardioComm beefed up their class-II OTC technology stack by introducing wireless, Bluetooth HeartCheck™ branded hardware and their GEMS™ Mobile Smart device app. “Plus, it allowed us to receive one to 12 leads of ECG data from handheld and wearable devices. All this while ensuring both on-demand data recording and continuous streaming,” adds Grima.

Additionally, CardioComm’s GEMS™ Mobile Smart device app also offers real-time ECG reporting capability in a very cost-effective manner. GEMS™ Mobile can save recorded ECGs which are then automatically forwarded to CardioComm’s SMART Monitoring ECG service with an option to forward ECGs directly into the patient’s cardiologist’s Electronic Medical Record. The devices can transmit recorded ECGs to a physician, a clinic, or CardioComm’s SMART monitoring ECG reading service. The consumer or patient using the device is also provided an ECG report through the GEMS™ Mobile app that is based on the company’s hospital ECG software. “Our HeartCheck™ ECG reports aren’t only beneficial to healthcare professionals but can also be used for ECG reading reimbursements by physicians,” furthers Grima.

“For third-party device manufacturers looking to bring new medical devices to market, a GEMS™ integration can leverage CardioComm’s existing software medical device clearances to secure new medical device clearances faster and with lower costs. ”  The sum benefit of these efforts is the plug-and-play options for the clients. CardioComm’s clients do not need to purchase new software platforms to support any new release, nor they need to move away from their trusted legacy hardware inventory. “In addition to providing end to end ECG solutions, we also provide access to any component of its technologies for integration into third-party platforms,” adds Grima. This includes access to prescription and OTC ECG devices, Smart device apps, a digital ECG viewer, hospital licensed ECG management solutions, an ECG reading/reviewing/reporting service, and integration with third-party medical records.

CardioComm’s success stories and partnership efforts are trailblazers and have almost become a word-of-mouth in the industry. They were instrumental in designing a customized remote 12 lead ECG monitoring solution for emergency and military applications for a UK based firm that was subsequently purchased by Philips. In another instance, they developed a mobile cardiac telemedicine (MCT) solution in partnership with Philips. This demonstrated CardioComm’s ability to augment a complicated in-house ECG management system to meet new cardiac telemetry monitoring needs early in the MCT market’s history.

The pioneering spirit of the CardioComm team continues to drive the company to bring new medical and OTC consumer innovations to the market to improve the quality of care. They have charted a six-years roadmap, starting with the completion of all R&D work within the next 12 months. This comprises of not only ECG bio-signal monitoring software and hardware, but also to expand into multiple bio-sign monitoring. CardioComm is also hopeful about acquiring the Health Canada and CE mark medical approvals for the sale of all their IP to deliver bolt-on technologies for their large patient monitoring platforms. “With 20+ years of service experience in the ECG monitoring domain, there is very little gap that we have not already done,” ends Grima.

“In 2012, CardioComm became North America’s first company to earn FDA and Health Canada OTC clearances”

“Our HeartCheck™ ECG reports aren’t only beneficial to healthcare professionals but can also be used for ECG reading reimbursements by physicians”


Etienne Grima


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