SmartCardia Receives FDA Clearance for its 14-Day 7-Lead ECG Real-Time Patch and Cloud Platform

Saturday, September 16, 2023

SmartCardia has gained FDA clearance for its 7-lead real-time ECG monitoring patch and cloud platform. This 7L patch is designed for easy wearing, cable-free, waterproof, and can provide continuous monitoring for up to 14 days.

SmartCardia's solution covers various cardiac monitoring needs, including screening, post-operative follow-up, and remote patient monitoring. It has been purpose-built to meet the stringent requirements of these different applications," said Srinivasan Murali, co-founder and CEO of SmartCardia.

One significant limitation of existing cardiac patches is the absence of multiple reciprocal leads necessary for accurate arrhythmia detection. SmartCardia's 7L patch offers exceptional P and QRS waves, unparalleled signal quality, and enables precise arrhythmia detection thanks to its 7 ECG leads.

According to the CTO, Francisco Rincon: "The patch transmits 100% of the ECG data in real-time, and automated analysis is conducted throughout the entire signal. Full-disclosure analysis allows for highly accurate arrhythmia detection, and the cloud platform allows clinicians to easily access and analyze ECG data at any time."

The 7L platform offers a real-time view of the patient's ECG, visual and audio alarms, automatic triggering of abnormal events with notifications to clinicians, and analysis of a comprehensive range of arrhythmias.

Both the patch and cloud platform have received CE Class IIa approval. SmartCardia is expanding its presence globally, with significant adoption in Europe and India and plans to reach new markets. The company has received recognition from Frost & Sullivan, which awarded it the 2022 Global New Product Innovation Award in cardiac monitoring.

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