MedPath

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. • SmartCardia's platform provides real-time ECG analysis, visual and audio alarms, and full-disclosure analysis, improving the accuracy of arrhythmia event detection. • This clearance validates SmartCardia's commitment to meeting stringent outpatient telemetry standards, offering accurate and timely arrhythmia detection.

SmartCardia has received FDA clearance for its mobile outpatient cardiac telemetry (OCT/MCT) system, which includes a seven-lead ECG monitoring patch and cloud platform. This clearance enables remote live monitoring of ECG data and immediate clinician notifications for significant arrhythmias. The system is designed for continuous monitoring for up to 14 days.
The SmartCardia patch is cable-free and waterproof. The seven ECG leads stream data live to the cloud, where it is immediately available for review. The cloud platform analyzes the ECG in real-time, providing outpatient telemetry notifications and full disclosure ECG analysis. Clinicians can view the patient’s ECG in real-time and receive visual and audio alarms.
The system's automated analysis is applied continuously across the entire signal, enabling accurate arrhythmia detection. The cloud platform features intuitive navigation, allowing clinicians to easily review and analyze ECG data at any moment.
According to Adam Kirchgessner, SmartCardia’s U.S. VP of sales, the patch and cloud platform are designed to meet stringent outpatient telemetry standards. He added that this clearance validates the company's commitment to accurate and timely detection of arrhythmia events.
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.

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 Prenatal Ultrasound Software Receives FDA Clearance

BrightHeart's AI software has received FDA 510(k) clearance for prenatal ultrasound evaluations of the fetal heart, aiding in the detection of congenital heart defects (CHDs).
The AI platform integrates into existing clinical workflows, automating key evaluation aspects to improve accuracy and save time for sonographers and OB/GYNs.

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 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.

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]
FDA clears outpatient cardiac telemetry for SmartCardia ECG patch - MassDevice
massdevice.com · Nov 13, 2024

SmartCardia received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its seven-lead ECG patch and cl...

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