The clearance comes for the company’s seven-lead live ECG montoring patch and cloud platform. SmartCardia designed its easy-to-wear, cable-free, waterproof patch for up to 14 days of continuous monitoring. The Lausanne, Switzerland-based company already has FDA clearance for extended Holter, event and Holter monitoring.
With the latest approval, the system now offers remote live monitoring for ECG and immediate clinician notifications for important arrhythmias.
The seven ECG leads stream live to the cloud, with ECG immediately available. The prorprietary cloud platform analyzes the ECG live to provide outpatient telemetry notifications and full disclosure ECG analysis. According to SmartCardia, it also features a real-time view of the patient’s ECG and can deliver visual and audio alarms.
All ECG data transmits live, with automated analysis applied continuously across the entire signal, The full-disclosure analysis enables highly accurate arrhythmia detection. Meanwhile, the cloud platform’s intuitive navigation allows clinicians to easily review and analyze ECG data at any moment.
“Many products available on the market do not have explicit FDA clearance for outpatient cardiac telemetry. Our patch and cloud platform are designed from the ground up to meet stringent outpatient telemetry standards, and this clearance validates our commitment and efforts. With an end-to-end patch to cloud, our solution provides accurate and on time detection of arrhythmia events,” said Adam Kirchgessner, SmartCardia’s U.S. VP of sales.
