FDA Clearance for SmartCardia ECG 7L Patch and Cloud Platform

"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.

One of the major limitations of cardiac patches in the market is the lack of multiple, reciprocal leads that enable accurate arrhythmia detection. SmartCardia's 7L patch provides excellent P and QRS waves, unprecedented signal quality and allows for accurate detection of arrhythmias thanks to its 7 ECG leads.

According to the 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.

Expanding global footprint

The patch and cloud platform are CE Class IIa approved. SmartCardia is expanding its global footprint with widespread adoption in Europe and India and quickly reaching new geographies. Speaking of the current momentum, SmartCardia's CEO & founder Srinivasan Murali adds "hundreds of clinicians and hospitals are using the SmartCardia patch and platform globally.

The company has been recognized by Frost & Sullivan with the 2022 Global New Product Innovation Award in cardiac monitoring.

(Press release - ES)