SmartCardia has secured the US Food and Drug Administration (FDA) approval for mobile outpatient cardiac telemetry (OCT/MCT) function on its 7-lead ECG patch and cloud platform.
The health technology company recently received FDA approval for its 7-lead (7L) ECG monitoring patch, for Extended Holter, Event and Holter monitoring.
The 7L patch is a cable-free, waterproof continuous monitoring device that can be used for up to 14 days to monitor 7-Lead ECG and vitals.
The expanded FDA approval allows the 7L patch to be used for remote live monitoring of patients’ ECG and immediately notify clinicians of important arrhythmias.
According to SmartCardia, its 7L Patch and cloud platform provide a unified solution for comprehensive cardiology care.
The unique patch supports multiple monitoring modes, such as Holter monitoring and mobile telemetry, allowing patients to easily transition between the modes remotely.
It allows clinicians to instantly access the data streamed live to the cloud from the patch’s seven ECG leads of the device.
The unique cloud platform provides real-time outpatient telemetry notifications and performs full ECG analysis, including detecting arrhythmias and other critical cardiac events.
In addition, the 7L ECG platform supports visual and audio alerts, enabling timely intervention based on live ECG data, said SmartCardia.
SmartCardia principal advisor Jag Singh said: “SmartCardia’s platform effectively addresses the primary needs of today’s electrophysiologists and cardiologists.
“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.”
The 7L patch system streams all ECG data live to the cloud, not just event-specific segments, where continuous automated analysis is applied across the entire signal.
Its full-disclosure analysis enhances the accuracy of arrhythmia detection, and the cloud platform’s user-friendly interface allows clinicians to review and analyse ECG data easily.
SmartCardia has recently acquired a US-based Independent Diagnostic Testing Facility (IDTF) and has in-network coverage with major insurance providers in the US.
The company’s 7L solution has received CE approval in Europe for ECG, analysis, cloud and vital signs tracking.
SmartCardia US sales VP Adam Kirchgessner said: “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 the cloud, our solution provides accurate and on-time detection of arrhythmia events.”
