SmartCardia's ECG Patch Receives FDA Clearance for Outpatient Cardiac Telemetry

Key Insights

• SmartCardia's seven-lead ECG patch and cloud platform secure FDA clearance for mobile outpatient cardiac telemetry, enhancing remote cardiac monitoring capabilities.
• The system offers continuous ECG monitoring for up to 14 days, streaming live data to the cloud for immediate clinician access and arrhythmia detection.
• SmartCardia's platform provides real-time ECG analysis, visual and audio alarms, and full-disclosure analysis, improving the accuracy of arrhythmia event detection.

SmartCardia has received FDA clearance for its mobile outpatient cardiac telemetry (OCT/MCT) system, which includes a seven-lead ECG monitoring patch and cloud platform. This clearance enables remote live monitoring of ECG data and immediate clinician notifications for significant arrhythmias. The system is designed for continuous monitoring for up to 14 days.

The SmartCardia patch is cable-free and waterproof. The seven ECG leads stream data live to the cloud, where it is immediately available for review. The cloud platform analyzes the ECG in real-time, providing outpatient telemetry notifications and full disclosure ECG analysis. Clinicians can view the patient’s ECG in real-time and receive visual and audio alarms.

The system's automated analysis is applied continuously across the entire signal, enabling accurate arrhythmia detection. The cloud platform features intuitive navigation, allowing clinicians to easily review and analyze ECG data at any moment.

According to Adam Kirchgessner, SmartCardia’s U.S. VP of sales, the patch and cloud platform are designed to meet stringent outpatient telemetry standards. He added that this clearance validates the company's commitment to accurate and timely detection of arrhythmia events.