Event Cardio Poised for FDA in 4th Quarter
Event Cardio Group announce that their new cardiac telemedicine system, NowCardio™ recently finished a successful audit for compliance to the Canadian Medical Devices Conformity Assessment System (CMDCAS) including ISO 13485:2003 compliance . The New York based medical device company (Publicly traded – OTCQB: ECGI) sees this as a big milestone in the efforts to acquire further regulatory approvals with both the FDA in the United States and Health Canada with their new arrhythmia monitoring system called NowCardio™
NowCardio™ is new platform to monitor ambulatory cardiac arrhythmias with capability to analyze patient ECG data and transmit in real-time. Event Cardio Group claims NowCardio™ to be the world’s first where a cardiac monitoring system can offer dual-functionality of both Holter monitoring and cardiac event (loop) monitoring.
Event Cardio Group is expecting a fast track approval for FDA by the 4th Quarter of 2015.