Sam Brusco, Associate Editor09.15.23
SmartCardia has gained U.S. Food and Drug Administration (FDA) clearance for its seven-lead (7L), real-time ECG monitoring patch and cloud SaaS (software as a service) platform.
The cable-free, waterproof 7L patch can be worn for continuous monitoring of 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", Srinivasan Murali, co-founder and CEO of SmartCardia told the press.
The 7L patch, according to SmartCardia, offers excellent P and QRS waves, better signal quality, and allows accurate arrhythmia detection because of its seven electrocardiogram (ECG) leads. In addition to real-time ECG views, 7L can provide audio and visual alarms. Automatic trigger of abnormal events send a notification to clinicians, and the platform can analyze a comprehensive set of arrythmias.
According to chief technology officer 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 patch and cloud platform are already CE Class IIa approved. The company was also recognized in Frost and Sullivan’s 2022 Global New Product Innovation Award for cardiac monitoring.
The cable-free, waterproof 7L patch can be worn for continuous monitoring of 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", Srinivasan Murali, co-founder and CEO of SmartCardia told the press.
The 7L patch, according to SmartCardia, offers excellent P and QRS waves, better signal quality, and allows accurate arrhythmia detection because of its seven electrocardiogram (ECG) leads. In addition to real-time ECG views, 7L can provide audio and visual alarms. Automatic trigger of abnormal events send a notification to clinicians, and the platform can analyze a comprehensive set of arrythmias.
According to chief technology officer 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 patch and cloud platform are already CE Class IIa approved. The company was also recognized in Frost and Sullivan’s 2022 Global New Product Innovation Award for cardiac monitoring.