SmartCardia announced today that it received FDA clearance for its seven-lead, real-time ECG monitoring patch and cloud platform.
The regulatory nod marks the second this week for wearable ECG technology. Samsung spinoff Wellysis picked up FDA clearance for its own ECG patch on Sept. 13.
Lausanne, Switzerland-based SmartCardia designed its easy-to-wear, cable-free, waterproof patch for up to 14 days of continuous monitoring.
“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,” said Srinivasan Murali, co-founder and CEO of SmartCardia. Murali said its ground-up design aims to meet the stringent requirements of these different applications.
With seven leads, the patch overcomes what SmartCardia calls “one of the major limitations of cardiac patches.” Often, they lack multiple, reciprocal leads that enable accurate arrhythmia detection. This technology provides P and QRS waves and strong signal quality for accurate detection of arrhythmias.
SmartCardia said its platform features real-time viewing for ECG data, plus visual and audio alarms. It provides an automatic trigger of abnormal events with notifications to clinicians, plus an analysis of a set of arrhythmias.
The patch and cloud platform also hold CE mark approval. SmartCardia said it continues to expand to new geographies with widespread adoption in Europe and India.
“100% of the ECG data, not just events, is transmitted in real-time, and the automated analysis is performed throughout the entire signal,” CTO Francisco Rincon said. “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.”