Technology | ECG Monitoring Services | July 13, 2017

Cardiologs ECG Analysis Platform Receives FDA Clearance

Cloud-based, artificial intelligence-powered ECG analysis solution aids healthcare professionals in screening for arrhythmias using ambulatory ECG monitoring recordings

Cardiologs ECG Analysis Platform Receives FDA Clearance

July 13, 2017 — Cardiologs Technologies SAS announced that it has received U.S. Food and Drug Administration (FDA) clearance of its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence (AI). Cardiologs aids physicians in screening for atrial fibrillation (AFib) and other arrhythmias using long-term ambulatory electrocardiogram (ECG) monitoring recordings. The Cardiologs system is also CE marked in Europe.

Atrial fibrillation (AFib) is the most common human arrhythmia, affecting about 33 million patients worldwide. AFib is 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. Indeed, recent stroke registries indicate that AFib is associated with one-third of all ischemic strokes.

“It is intuitive that screening for AFib and subsequent anticoagulant treatment should reduce the stroke burden, which is the basis of guideline recommendations to screen for AFib in persons over the age of 65,” said Arnaud Rosier, M.D., cardiac electrophysiologist at the Hôpital Jacques Cartier, Massy, France. “Unfortunately, current R-R interval based methods to detect AFib are characterized by an inferior positive predictive value (PPV) of under 59 percent, leading to misdiagnoses, mostly false positives, that add significant cost to the healthcare system while burdening healthcare resources and placing unnecessary stress on misdiagnosed patients or putting undiagnosed patients in harm’s way.”

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 the technology to identify relevant events. It is especially powerful for long-term recordings that used to require a very laborious manual analysis process, according to Yann Fleureau, co-founder and CEO of Cardiologs Technologies. He said the neural network was developed using more than 500,000 recordings, and the training dataset continues to grow.

When defining the reliability of diagnosing AFib and other arrhythmias, the term positive predictive value (PPV) refers to the percentage of true positive cases among total cases detected. Conventional PPV for detecting AFib is less than 59 percent. The PPV for Cardiologs’ detection of AFib was 91 percent, included in the cleared FDA submission. In addition, also as included in the cleared FDA submission, Cardiologs’ sensitivity for detecting AFib was reported to be 97 percent (the percentage of positive cases truly identified) and was superior to  conventional methods of detecting AFib and other arrhythmias. Cardiologs’ study results have been published in the European Journal of Preventive Cardiology (2016, Vol. 23(2S 41-55). The study’s investigators concluded: “This (Cardiologs) method may be more reliable and accurate than previous methods in the diagnosis of AFib on long-duration ambulatory ECG and other monitoring devices.”

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