SmartCardia receives US FDA clearance for 7L monitoring patch

SmartCardia 7L Patch

SmartCardia has received US Food and Drug Administration (FDA) clearance for its seven-lead real-time electrocardiogram (ECG) monitoring patch and cloud platform.

SmartCardia’s 7L patch is cable-free, waterproof and can be used for continuous monitoring for up to 14 days.

“SmartCardia’s 7L patch and cloud platform is a single solution that covers the entire spectrum of cardiac monitoring including screening, post-operative follow-up, and remote patient monitoring. It has been designed ground-up to meet the stringent requirements of these different applications,” said Srinivasan Murali, co-founder and CEO of SmartCardia.

According to the company’s CTO, Francisco Rincon: “100% of the ECG data, not just events, is transmitted in real-time, and the automated analysis is performed throughout the entire signal. While full-disclosure analysis allows for highly accurate arrhythmia detection, easy navigation on the cloud platform allows the clinician to quickly view and analyze ECG at any point in time.”

The 7L platform features real-time view of the patient’s ECG and can deliver visual and audio alarms. It also provides automatic trigger of abnormal events with notifications to clinicians, and analysis of a comprehensive set of arrhythmias.

The patch and cloud platform are CE Class IIa approved. SmartCardia is expanding its global footprint with adoption in Europe and India and reaching new geographies.


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