SmartCardia’s 7-Lead ECG Patch Wins FDA Nod for Outpatient Cardiac Telemetry

SmartCardia has earned U.S. Food and Drug Administration (FDA) clearance for Mobile Outpatient Cardiac Telemetry (OCT/MCT) for its seven-lead live ECG monitoring patch and cloud platform.

This follows the company’s previous FDA clearance for extended holter, event, and holter monitoring.

With this new approval, SmartCardia’s solution can be used for remote live monitoring of a patient’s ECG and immediately alert clinicians about important arrhythmias. According to the SmartCardia, its 7L patch is easy to wear, cable-free, waterproof, and can continuously monitor for up to 14 days.

The patch can be used in modes from holter to mobile telemetry. It can also be remotely transitioned between them. The seven ECG leads are streamed live to the cloud, where the ECG becomes immediately available.

The company’s cloud platform analyzes the ECG live to offer outpatient telemetry notifications and full disclosure ECG analysis. The 7L platform also features real-time ECG view and can send visual and audio alarms. All ECG data is transmitted live, with automated analysis applied continuously across the whole signal.

SmartCardia also recently finished an acquisition of a U.S. Independent Diagnostic Testing Facility (IDTF) to gain control over the full ecosystem. The company has in-network coverage with major insurance providers for the different monitoring modalities across the U.S.

The company’s solution also has CE Class IIa approval in Europe for ECG, analysis, cloud, and vital signs.

“SmartCardia’s platform effectively addresses the primary needs of today’s electrophysiologists and cardiologists,” said Dr. Jag Singh from Harvard Medical School and Massachusetts General Hospital and Principal Advisor of SmartCardia. “Its 7-lead ECG delivers unparalleled clinical accuracy, the live monitoring allows for immediate notifications, and the reusable sensor with a low cost disposable patch promotes high operational efficiency.”

“Many products available on the market do not have explicit FDA clearance for outpatient cardiac telemetry. Our patch and cloud platform are designed from the ground up to meet stringent outpatient telemetry standards, and this clearance validates our commitment and efforts. With an end-to-end patch to cloud, our solution provides accurate and on time detection of arrhythmia events,” said Adam Kirchgessner, SmartCardia’s U.S. VP of Sales.