This comes on the heels of SmartCardia’s prior FDA clearance for Extended Holter, Event and Holter monitoring. With this approval, SmartCardia’s solution can be used for remote live monitoring of patients’ ECG and immediately notify clinicians for important arrhythmias.

SmartCardia’s patch and cloud platform is a single solution for complete cardiology practice: the patch can be used in any of the modes from holter to mobile telemetry and can also be remotely transitioned between them seamlessly for patients. The 7 ECG leads are streamed live to the cloud, where the ECG is immediately available. The proprietary cloud platform analyses the ECG live to provide outpatient telemetry notifications and full disclosure ECG analysis. The 7L platform features real-time view of the patient’s ECG and can deliver visual and audio alarms.

“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.”