The seven-lead patch enables continuous, real-time ECG monitoring for up to 14 days with immediate arrhythmia alerts to clinicians.
Summary: SmartCardia has received FDA clearance for its seven-lead ECG patch, designed for mobile outpatient cardiac telemetry. This cable-free, waterproof device allows for continuous heart monitoring for up to 14 days, with live data streamed to the cloud for real-time analysis. The system’s cloud platform not only notifies clinicians of arrhythmias immediately but also provides comprehensive ECG analysis. This clearance builds on SmartCardia’s previous approvals for holter and event monitoring.
Key Takeaways:
- FDA Clearance Expands Capabilities: The seven-lead ECG patch allows for continuous outpatient telemetry monitoring, enabling immediate detection of arrhythmias and other heart conditions.
- Versatile Monitoring Solution: The patch can be used in various monitoring modes, switching between holter, event, and telemetry functions while streaming live data to clinicians.
- Efficiency and Coverage: With reusable sensors, a low-cost disposable patch, and “in-network” insurance coverage, SmartCardia’s solution aims to enhance operational efficiency and accessibility in cardiac care.
SmartCardia has received US Food and Drug Administration (FDA) clearance for mobile outpatient cardiac telemetry for its seven-lead live ECG monitoring patch and cloud platform.
SmartCardia’s 7L patch is cable-free, waterproof, and can be used for continuous monitoring for up to 14 days. This comes on the heels of SmartCardia’s prior FDA clearance for extended holter, event, and holter monitoring. With this clearance, SmartCardia’s solution can be used for remote live monitoring of patients’ ECG and immediately notify clinicians of 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 seven 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 a 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,” says Jag Singh, MD, PhD, from Harvard Medical School and Massachusetts General Hospital and principal advisor of SmartCardia, in a release. “Its seven-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.”
On-Time Detection of Arrhythmia Events
All ECG data—not just events—is transmitted live, with automated analysis applied continuously across the entire signal. This full-disclosure analysis enables “highly accurate” arrhythmia detection, and the cloud platform’s “intuitive navigation allows clinicians to easily review and analyze ECG data at any moment,” according to a release from the company.
“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,” says Adam Kirchgessner, SmartCardia’s US vice president of sales.
SmartCardia recently completed the acquisition of a US Independent Diagnostic Testing Facility. SmartCardia has “in-network” coverage with major insurances for the different monitoring modalities across the US.
SmartCardia’s solution has CE Class IIa approval in Europe for ECG, analysis, cloud, and vital signs.
Photo caption: SmartCardia 7L Patch
Photo credit: PRNewsfoto/SmartCardia
