Cardiologs Technologies receives FDA approval for ECG Analysis Platform


France-based Cardiologs Technologies has secured an approval from the US Food and Drug Administration (FDA) for its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence (AI).

The Cardiologs system is designed to help physicians in screening atrial fibrillation (AFib) and other arrhythmias using long-term ambulatory ECG monitoring recordings.

It is also developed to recognise patterns in a cardiac signal for quick and precise analysis of arrhythmias, including AFib, in a similar intuitive manner as expert cardiologists.

CardiologsTechnologies noted that AFib is the most common human arrhythmia, affecting around 33 million patients across the globe.

AFib is also a growing problem in cardiovascular disease and is associated with an increased risk of severe stroke, heart failure and death. AFib is often asymptomatic, with stroke as the first manifestation.

"It is especially powerful for long-term recordings that used to require a very laborious manual analysis process."

Various recent stroke registries have pointed out that AFib is linked with one-third of all ischemic strokes.

Cardiologs Technologies co-founder and CEO Yann Fleureau said: “Cardiologs is a game-changer for arrhythmia screening.

“A cardiologist recovers a digital ECG from any compatible cardiac monitoring device - such as a Holter monitor, smartwatch, ECG patch or even a connected t-shirt - then uploads it to the Cardiologs cloud and is able to immediately leverage our technology to identify relevant events.

“It is especially powerful for long-term recordings that used to require a very laborious manual analysis process.”

So far, Cardiologs Technologies has trained a neural network using more than 500,000 recordings.