The NowCardio heart monitoring system, Event Cardio Group, Inc.’s core product, has been cleared for sale by Health Canada as a Class 2 Medical Device License and distribution will commence this month.
The system is a noninvasive continuous heart monitoring device that is both leadless and wireless, offering the functionality of Holter monitoring, event monitoring, mobile cardiac telemetry and real-time streaming of all ECG data within a single device.
The heart monitor involves a single-lead ECG patch that allows patients to be remotely monitored for extended periods of time to obtain important data which is continuously transferred to a data center for immediate analysis.
It incorporates several features designed to improve patient adherence, including: No wired leads; wireless transmitter; automatic arrhythmia detection; patient-triggered alarm; small footprint and 24/7 patient support.
The unit also incorporates several features designed to enhance diagnostic yield, including: Advanced automated ECG analysis software; superior noise reduction; extended monitoring up to 32 days; real-time streaming of all ECG data; mobile device support; and custom electrodes without skin prep.
“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,” Vincenzo Basile MD, BEd, CSCN, FRCPC, a neurologist and medical director of hospital stroke programs, said.
The medical device license was issued to Contex International Technologies (Canada) Inc., the engineering arm of Event Cardio Group. The license covers four components of the NowCardio system: The sensor, electrode, smart device and charger.
Event Cardio Group, Inc. is a developer of medical diagnostic equipment that focuses on the detection, and preventive treatment, of high-risk diseases.