CardioComm Solutions - a Leader in Customized Remote Patient ECG Monitoring and Device Partnerships
CardioComm Solutions, Inc. (“CardioComm” or the “Company”) has been a pioneer in developing proprietary and specialized electrocardiogram (“ECG”) software for the diagnosis of arrhythmias and the management of cardiac patients outside of the hospital environment. The Company’s advances have been at the forefront of revolutionizing mobile and remote cardiac monitoring systems in the medical market for over twenty years, and eight years in the consumer over-the-counter(“OTC”) health and wellness markets. Their products are sold worldwide. CardioComm has earned ISO 13485:2016 under the Medical Device Single Audit Plan (“MDSAP”) certification (Canada and US), is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).
The detection of cardiac arrhythmias has traditionally required the use of expensive ECG monitors only obtainable after seeing a physician or a visit to a hospital.In 2012, CardioComm became the first company in North America to be granted FDA and Health Canada OTC clearances for the manufacturing, marketing and selling of ECG devices direct to consumers without the need of a physician’s prescription. In 2019, the Company added wireless, Bluetooth HeartCheck™ branded hardware and their GEMS™ Mobile Smart device app to their list of class II, medically cleared for OTC use technologies. The technologies allow one to 12 leads of ECG data to be received from handheld and wearable devices where ECG data is recorded on demand or is continuously streamed. CardioComm’s own HeartCheck™ brand of devices are gaining traction for use by healthcare and telemedicine organizations. This functionality allows their patients to record and define their heart health anywhere and anytime symptoms may occur.
The innovative HeartCheck™/GEMS™ Mobile solution enables a cost effective and reliable remote monitoring interaction between individuals living their lives outside of the hospital and their doctors and health care providers.
The Company isnow focusing on the promotion of its own HeartCheck™ hardware and GEMS™ software brands and will move into multiple bio-signal monitoring in addition to its traditional ECG monitoring. With new hospital use software for long term (Holter/event) reporting being readied for clearance and continued releases of hardware and software solutions for consumer/OTC heart health self-monitoring, the Company is positioned to attract a large market share from where it had previously been absent.
In addition to the company providing hardware and software solutions to meet remote patient monitoring needs, CardioComm also provides an ECG reading service through its GEMS Mobile Smart device mobile app. Consumers, and physicians monitoring their patients remotely, can benefit from having ECGs reviewed rapidly and very cost effectively 7/24/365.
For third-party device manufacturers looking to bring new medical devices to market, a GEMS™ integration can leverage CardioComm’sexisting software medical device clearances to secure new medical device clearances faster and with lower costs. This is a key and focal corporate selling point. In 2019, CardioComm secured OTC medical device clearance for their new HeartCheck™ handheld CardiBeat ECG device manufactured by an OEM partner. The Company also secured Health Canada clearance for continued access and sale of hospital/physician prescribed ECG devices,compatible with CardioComm’s GEMS™ software,from an established American device manufacturer by leveraging CardioComm’s ISO 13485:2016 certification under MDSAP where the American company did not have the MDSAP designation.
The sum benefit of these efforts is that CardioComm’s clients do not need to purchase new software platforms to have access to newly released ECG devices nor do they need to move away from the use of their trusted legacy hardware inventory. CardioComm watches the market for innovation announcements, technology shifts, regulatory changes, partnership opportunities and human needs issues so that their customers stay in step with such changesand safely maintain their practice for caring for their cardiac patients.
In addition to providing “total” ECG solutions, CardioComm can also provide access to any component of its technologies for integration into third party platforms. 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.
With the goal to stay ahead of technology changes, CardioComm’s ECG software development has not relented CardioComm has identified the following technologies as a priority for the next 18 months:
• GEMS™ FLEX, an advanced ECG monitoring system that uses algorithms and AI;
• GEMS™ Triage, an automated feedback report to let OTC device users know if the ECG they recorded was of good quality and if not, to repeat the recording to ensure a good ECG is used to rule in or rule out the presence of an arrhythmia;
• A HeartCheck™ multi-lead and Bluetooth connected ECG patch device;
• An ECG tattoo sensor that will be ultra-thin, ultra-light and low cost;
• A GEMS™ based telemed solution with multiple biomarkers monitored in addition to ECGs; and,
• Compatible wearable devices such as smart garments and watches.
CardioComm possesses an extensive 20+ year history of servicing the ECG monitoring market and their well-trained teamowns a unique knowledge base. There is little in the ECG world that this company has not already done, nor that it will not be able to do, in assisting their customers with remote patient monitoring needs as well as providing consumers with medically credible heart monitoring solutions so they may be able to take control of their own heart health.