Electrocardiography

Electrocardiograms (ECG) are a primary cardiac diagnostic test that measures the electrical activity in heart to identify overall cardiac function, arrhythmias and areas of ischemia and infarct. Standard 12-lead ECG breaks the 3D structure of the heart into 12 zones, each showing the electrical activity in that specific area of the heart. This narrows down areas where there are issues with coronary artery disease or electrophysiology issues. Many ambulatory heart monitors and consumer-grade ECG monitors use fewer leads so are less specific as to cardiac conditions or location of abnormal heart rhythms, but can show an issue that requires further diagnostic testing or treatment.

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The U.S. Food and Drug Administration (FDA) has granted the first pediatric indication for use for an implantable cardiac monitor to Medtronic. The Linq II Insertable Cardiac Monitor (ICM) system is the first such device receive 510(k) clearance for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.

FDA grants new pediatric indication for Medtronic Linq II implantable cardiac monitor 

The FDA granted the first pediatric indication for an implantable cardiac monitor. The Linq II can be used in pediatric patients over the age of 2 for up to 4.5 years of long-term, continuous monitoring. 

CathVision’s ECGenius EP Recording System, a new solution designed to capture high-fidelity, low-noise electrocardiogram (ECG) recordings for the diagnosis and treatment of arrhythmias such as atrial fibrillation (AFib).

Heart rhythm specialists raise $7.2M to fund advances for FDA-cleared ECG system

The new funding all came from existing investors. “Reinvesting in the company demonstrates confidence in our innovation," CathVision's CEO said about the news. 

Ancora Heart AccuCinch Ventricular Restoration System heart failure FDA

Regulatory Roundup: FDA clears AI-powered Apple Watch competitor, grants breakthrough designation to new heart failure device

Ancora Heart received the FDA’s breakthrough device designation for its AccuCinch Ventricular Restoration System, a new minimally invasive transcatheter device designed for the treatment of heart failure.

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Judge says Apple violated ECG patents, making U.S. import ban of Apple Watches a possibility

A judge from the U.S. International Trade Commission has said Apple violated multiple AliveCor patents. This story, however, is far from over.

Abbott’s FreeStyle Libre 3 glucose monitor gains FDA clearance

Regulatory Roundup: FDA clears 2 new devices, grants breakthrough designation to advanced AI model

Catch up on several recent FDA announcements, including an update on the agency's response to the COVID-19 pandemic. 

VIDEO: How to implant a Linq implantable cardiac monitor

The Medtronic Linq and Linq II implantable cardiac monitors (ICM) have become some of the most popular ICM devices on the market, partly because they are easy to insert.

Fitbit’s latest AFib algorithm receives FDA clearance, will be available ‘soon’

The new algorithm was designed to evaluate a user's heart rhythm while they are still or even sleeping. 

VIDEO: 4 predictions on key cardiac technologies for the coming years

Mass General cardiologist and Harvard professor Ami Bhatt, MD, predicts upcoming paradigm shifts in cardiology over the next decade. 

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