MedPath

SmartCardia's 7-Lead ECG Patch Receives FDA Clearance for Outpatient Cardiac Telemetry

• SmartCardia's 7-lead ECG patch and cloud platform have received FDA clearance for Mobile Outpatient Cardiac Telemetry (OCT/MCT). • The patch allows for continuous ECG monitoring for up to 14 days and seamless transition between Holter and mobile telemetry modes. • The platform features real-time ECG data streaming to the cloud, providing immediate notifications and full-disclosure ECG analysis for clinicians. • SmartCardia's solution aims to improve arrhythmia detection accuracy and operational efficiency for cardiologists and electrophysiologists.

SmartCardia has announced FDA clearance for its 7-lead ECG patch and cloud platform for Mobile Outpatient Cardiac Telemetry (OCT/MCT), marking a significant advancement in remote cardiac monitoring. The clearance enables continuous monitoring for up to 14 days, offering clinicians real-time data and immediate notifications for critical arrhythmias.
The SmartCardia 7L patch is designed for ease of use, being cable-free and waterproof. It builds upon the company's previous FDA clearances for Extended Holter, Event, and Holter monitoring, providing a comprehensive solution for cardiology practices. The patch can be remotely transitioned between monitoring modes, enhancing patient convenience and clinical flexibility.

Enhanced Accuracy and Real-Time Monitoring

The 7-lead ECG data is streamed live to SmartCardia's proprietary cloud platform, where it undergoes continuous analysis. This full-disclosure analysis allows for highly accurate arrhythmia detection, and the platform's intuitive interface facilitates easy review and analysis of ECG data by clinicians at any time. Visual and audio alarms are also delivered for immediate notification of critical events.
According to Dr. Jag Singh from Harvard Medical School and Massachusetts General Hospital, and Principal Advisor of SmartCardia, "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."

Addressing Unmet Needs in Cardiac Monitoring

Many existing products lack explicit FDA clearance for outpatient cardiac telemetry. SmartCardia's patch and cloud platform are specifically designed to meet stringent outpatient telemetry standards, ensuring accurate and timely detection of arrhythmia events. Adam Kirchgessner, SmartCardia's US VP of Sales, emphasized the company's commitment to providing an end-to-end solution from patch to cloud.

Expanding Capabilities and Global Reach

SmartCardia has recently acquired a US Independent Diagnostic Testing Facility (IDTF), further integrating its services and ensuring control over the entire ecosystem. The company also has "in-network" coverage with major insurers across the US for various monitoring modalities. SmartCardia's solution holds CE Class IIa approval in Europe for ECG, analysis, cloud, and vital signs, and the company is actively expanding its presence in multiple countries.
SmartCardia was also honored with the 2022 Global New Product Innovation Award in cardiac monitoring from Frost & Sullivan, highlighting its commitment to innovation and excellence in the field.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

AccurKardia's AI-Powered Hyperkalemia Detection Software Receives FDA Breakthrough Device Designation

AccurKardia's AK+ Guard, an AI-powered software, has received FDA Breakthrough Device Designation for hyperkalemia detection using Lead I ECG data.
AK+ Guard aims to detect moderate to severe hyperkalemia episodes, potentially preventing sudden cardiac arrest through early alerts.

HeartBeam Submits FDA Application for 12-Lead ECG Synthesis Software

HeartBeam has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software, designed to assess various cardiac rhythms and arrhythmias.
The submission is supported by data from the VALID-ECG pivotal study, involving 198 patients across five clinical sites, demonstrating clinical equivalence to standard ECGs.

LifeSignals' UbiqVue 2A System Receives FDA Clearance for Continuous Wireless Patient Monitoring

LifeSignals' UbiqVue 2A system, featuring a wearable biosensor, has gained FDA 510(k) clearance for continuous remote patient monitoring in diverse settings.
The biosensor, worn on the chest, monitors 13 physiological parameters, including SpO2, ECG, respiration rate, and body temperature, transmitting data securely to a cloud-based system.

FDA Clears Medtronic's InPen App, Advancing Smart MDI System Launch

The FDA has cleared Medtronic's InPen app, which features missed meal dose detection, a crucial step for launching its Smart MDI system.
The Smart MDI system integrates the InPen smart insulin pen with Simplera, Medtronic's continuous glucose monitor (CGM), approved by the FDA in August.

BrightHeart's AI-Powered Fetal Heart Ultrasound Software Receives FDA Clearance

BrightHeart has secured FDA 510(k) clearance for its AI software, designed to aid in prenatal ultrasound evaluations of fetal hearts, enhancing the detection of congenital heart defects.
The AI technology integrates into current clinical workflows, assisting sonographers and OB/GYNs in assessing fetal hearts and improving the accuracy of early abnormality detection.

SmartCardia's ECG Patch Receives FDA Clearance for Outpatient Cardiac Telemetry

SmartCardia's seven-lead ECG patch and cloud platform secure FDA clearance for mobile outpatient cardiac telemetry, enhancing remote cardiac monitoring capabilities.
The system offers continuous ECG monitoring for up to 14 days, streaming live data to the cloud for immediate clinician access and arrhythmia detection.

Fourth Frontier's Frontier X Plus ECG Monitor Receives FDA Clearance

Fourth Frontier's Frontier X Plus, a single-lead continuous ECG monitor, has received 510(k) clearance from the U.S. FDA.
The device monitors and classifies cardiac rhythms, including Bradycardia, Tachycardia, Normal Sinus Rhythm, and Atrial Fibrillation.

AccurKardia and iCardio.ai Advance AI-Powered Cardiac Screening with FDA Designations

AccurKardia received FDA Breakthrough Device designation for its AI-driven ECG software designed to detect aortic valve stenosis (AVS) using existing ECG data.
iCardio.ai obtained FDA 510(k) clearance for its AI software, EchoMeasure, which automates echocardiographic interpretation and streamlines imaging workflows.

Dong-A ST's Hicardi+ H100 ECG Monitoring Platform Receives FDA Clearance

Dong-A ST's Hicardi+ H100, a patch-type ECG monitoring device, has received 510(k) clearance from the U.S. FDA, including its cloud-based software LiveStudio.
The device, developed by Meju, measures ECG and heart rate for long-term monitoring and is already used in Korea for cardiac disease screening.

Reference News

[1]
SmartCardia Receives FDA Clearance for Outpatient Cardiac Telemetry for Its 7-Lead ECG ...
prnewswire.com · Nov 13, 2024

SmartCardia received FDA clearance for its 7-lead live ECG monitoring patch and cloud platform, enabling continuous outp...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy