Smartcardia SA has gained U.S. FDA clearance for its seven-lead live ECG monitoring patch and cloud platform, allowing for mobile outpatient cardiac telemetry. This innovative solution enables remote monitoring of patients’ ECGs and provides immediate notifications to clinicians in case of arrhythmias.
The seven-lead patch is designed to be easy to wear, cable-free, and waterproof, allowing for continuous monitoring for up to 14 days. This approval follows Smartcardia’s earlier FDA clearances for extended Holter and event monitoring systems.
Dr. Jag Singh from Harvard Medical School praised the platform, stating that it addresses the critical needs of electrophysiologists and cardiologists. The system’s live monitoring capabilities ensure timely notifications, while the reusable sensor and low-cost disposable patch enhance operational efficiency.
Smartcardia’s cloud platform continuously analyzes all ECG data, not just events, enabling highly accurate arrhythmia detection. Clinicians can easily navigate the system to review and analyze ECG data in real time.
Adam Kirchgessner, Smartcardia’s U.S. VP of Sales, emphasized the significance of this clearance, noting that many existing products lack explicit FDA approval for outpatient cardiac telemetry. He highlighted that their solution is built to meet stringent outpatient telemetry standards.
In addition to this new clearance, Smartcardia has recently acquired a U.S. Independent Diagnostic Testing Facility (IDTF), further enhancing its capabilities in cardiac monitoring. The company also has CE Class IIa approval in Europe and is expanding its presence globally.
Smartcardia continues to innovate in cardiac monitoring, providing valuable tools for healthcare providers and improving patient outcomes through advanced technology.
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