Heart monitoring system developer Event Cardio said today it won Health Canada approval for its NowCardio heart monitoring system, and will begin distribution in Canada this month.
The NowCardio device is a non-invasive, wireless continuous heart monitoring device which allows for Holter monitoring, automatic arrhythmia detection, patient triggered alarms and real-time streaming of all ECG data, the New York-based company said.
“After nearly 5 years of hard work and dedication, we have achieved a key milestone in our commercialization strategy for NowCardio with the issuance of this Health Canada medical device license. This approval enables us to provide clinicians and other customers in Canada with a unique tool that can provide comprehensive and reliable data about patients’ heart health. All of the members of our development team are to be commended for their efforts. We believe that commercialization of NowCardio will allow us to become a key player in the rapidly growing heart monitoring sector and that we are well-positioned to capitalize on this opportunity. We look forward to meeting with potential customers in Canada and applying for regulatory clearances in other countries,” CEO John Bentivoglio said in a press release.
The device is composed of a single-lead ECG patch and wireless transmitter, and allows for extended monitoring for up to 32 days, Event Cardio said.
“The NowCardio device is a lightweight, comfortable and waterproof solution to real-time, beat-to-beat cardiac monitoring and undoubtedly will offer several advantages over the current standards. The real-time streaming of beat-to-beat data offers more rapid detection of paroxysmal atrial fibrillation and early identification is vital to stroke prevention. Its small size and leadless design allows patients to be monitored without others noticing they have it on and its waterproof design allows patients to be monitored without interfering with showering or swimming. Overall it is one of the best designs I have seen from a cardiac monitor perspective,” Dr. Vincenzo Basile said in a press release.
“NowCardio offers heart patients and their caregivers a novel and comprehensive paradigm for cardiac event monitoring. The leadless design will increase patient comfort and compliance while providing healthcare providers with expanded data for the detection of arrhythmia. We are confident that this device will prove to be invaluable in several clinical settings and will quickly win favor from clients as they learn about the unique advantages it offers compared to the existing standard of care in the cardiac monitoring space,” advisory board member Dr. Antonio Rocca of the University of Toronto said in prepared remarks.