Switzerland-based SmartCardia has received US Food and Drug Administration (FDA) clearance for its seven-lead (7L) real-time electrocardiogram (ECG) monitoring patch and cloud platform.
The 7L patch is said to be comfortable to wear, cable-free, and waterproof, and it may be used for up to 14 days of continuous monitoring.
The cloud platform and patient monitoring patch maker designed the patch to offer excellent P and QRS waves, unique signal quality and enable accurate arrhythmias detection.
According to SmartCardia, the 7L platform provides a real-time view of the patient’s ECG and can provide audio and visual alerts.
It is also said to offer automatic trigger of abnormal events with notifications to clinicians, and analysis of a comprehensive set of arrhythmias.
SmartCardia co-founder and CEO Srinivasan Murali said: “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.”
The patient monitoring patch maker said that the device outsmarts the existing cardiac patch in the market in terms of the presence of multiple reciprocal leads that enable accurate detection of arrhythmia.
The cloud platform and patch have CE Class IIa approval, SmartCardia added.
The company is expanding its geographic reach with extensive use in Europe and India and swift expansion into other countries.
SmartCardia CTO Francisco Rincon said: “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 analyse ECG at any point in time.”
