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.

FDA clears 12-lead, cable-free home ECG monitoring system
The new technology synthesizes signals from a credit card-sized device into a 12-lead ECG representation.
Universal heart screening for all athletes? Not so fast, cardiologists warn
Mandates for universal ECG screening are gaining momentum as a way to combat the risk of SCA. However, the ACC warned, modern healthcare systems were not built to withstand such a rise in demand. These mandates will also result in higher costs and other unintended consequences.
ECG market keeps evolving thanks to AI, home monitoring and Epic integration
For years, the ECG market was relatively static. According to a new report, however, things are rapidly changing.
FDA clears next-generation platform for AI-enabled ECG evaluations
AccurECG 2.0 was designed to interpret a total of 13 different rhythm classifications, including atrial fibrillation, atrial flutter and ventricular tachycardia.
AI flags hard-to-detect heart disease in seconds
The new deep learning algorithm is capable of detecting signs of coronary microvascular dysfunction in seconds.

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a 12-lead electrocardiogram (ECG) synthesis software for home assessment of arrhythmias. This clearance follows HeartBeam’s successful appeal of a prior "not substantially equivalent (NSE) determination.

FDA clears 12-lead, cable-free home ECG monitoring system

The new technology synthesizes signals from a credit card-sized device into a 12-lead ECG representation.

Universal heart screening for all athletes? Not so fast, cardiologists warn

Mandates for universal ECG screening are gaining momentum as a way to combat the risk of SCA. However, the ACC warned, modern healthcare systems were not built to withstand such a rise in demand. These mandates will also result in higher costs and other unintended consequences.

The HeartBeam AIMIGo device is approximately the size of a credit card and uses the company’s patented 3D vectorelectrocardiography (3D VECG) technology to capture signals from three different projections and deliver a synthesized 12-lead ECG.

ECG market keeps evolving thanks to AI, home monitoring and Epic integration

For years, the ECG market was relatively static. According to a new report, however, things are rapidly changing.

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FDA clears next-generation platform for AI-enabled ECG evaluations

AccurECG 2.0 was designed to interpret a total of 13 different rhythm classifications, including atrial fibrillation, atrial flutter and ventricular tachycardia.

AI flags hard-to-detect heart disease in seconds

The new deep learning algorithm is capable of detecting signs of coronary microvascular dysfunction in seconds.

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FDA clears next-generation cardiac mapping software

San Diego-based Vektor Medical first secured FDA clearance for the AI-powered technology back in 2021. This updated announcement covers the latest version, which includes atrial flutter mapping and several other new features.

FDA clears new ‘smart shirt’ for real-time cardiopulmonary monitoring

According to Hexoskin, the newly cleared technology offers significant value for hospitals and health systems as well as researchers conducting clinical trials.

FDA clears AI-powered ‘thermometer of the future’ with ECG sensors

BeamO combines electrocardiogram sensors, a stethoscope and a thermometer into a single device that patients can use at home to learn more about their health. Findings can then be submitted for a cardiologist to review.