By Staff Reports
(DGIwire) – For decades, the standard in mobile heart monitoring was a bulky device with wires and electrodes that connected to the patient. According to Medical Device and Diagnostic Industry, patients wore these so-called Holter monitors for one or two days to record arrhythmias. Although they did not replace 12-lead ECGs, Holter monitors gave doctors a way of capturing a record of a patient’s heartbeat outside a clinical setting. But Holters are bulky and many patients dislike them. Also, reports MD+DI, they record heartbeat data for only up to 48 hours—if patients manage to keep them on that long.
Accurate heart monitoring is important because arrhythmias are prevalent among Americans and expensive for the healthcare system. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation affects between 2.7 million and 6.1 million Americans and costs an estimated $6 billion annually. Meanwhile, heart failure affects approximately 5.1 million Americans and kills half of those who are diagnosed within five years, the CDC says, leading to an estimated $32 billion in annual healthcare costs.
Technology has stepped in to deal with this state of affairs. The global cardiac monitoring and cardiac rhythm management devices market is expected to top $26 billion by 2020, up from $21 billion in 2015, according to MarketsandMarkets. Naturally, the race is on for more conveniently designed devices that will appeal to those who need them.
“The future of heart monitoring is smaller, mobile and in the cloud,” says John Bentivoglio, CEO of Event Cardio Group, a developer of medical diagnostic equipment for the detection and preventive treatment of high-risk diseases. “Technological developments have made possible a new generation of devices that will allow patients to shower, sleep and carry on their lives in ways that Holter monitors do not. And they offer accuracy that equals or exceeds what Holters can offer.”
Event Cardio Group has developed NowCardio™, a non-invasive continuous heart monitoring device that is both leadless and wireless, offering the functionality of Holter, event and mobile cardiac telemetry in a single device. While other devices offer combinations of these tests, not all offer all three in a single device that is leadless and wireless—plus the added advantage of real-time streaming of all ECG data for medical professionals. And patients can even go swimming with it. Ultimately, the design of the device may help to improve patient compliance, leading to a higher diagnostic yield. According to a study published in Current Cardiology Reviews, traditional Holter monitoring only yields 6.2 percent compliance.
In June 2016, NowCardio was cleared for sale within Canada upon receipt of a Class 2 Medical Device License from Health Canada. Event Cardio Group plans to apply for 510(k) clearance from the U.S. Food and Drug Administration and then a C.E. mark in the EU.
“We are at the dawn of the next generation of heart monitoring devices, with breakthroughs in performance, size and flexibility that have the potential for great impact on the cardiac monitoring market—and ultimately improving quality of life,” adds Bentivoglio.