FDA Clearance for “Game Changing” Cardiologs ECG Analysis Platform

Cardiologs Technologies SAS has received FDA clearance of its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence (AI).

Background

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.

Headquartered in Paris, Cardiologs Technologies is a privately held company offering the “Cardiologs ECG Analysis” platform to aid cardiologists in screening for AFib and other arrhythmias using long-term ambulatory ECG monitoring recordings. In essence, teh Cardiologs system receives recordings from any digital cardiac monitoring device, then through its algorithms, automatically detects and presents arrhythmias by clinical relevance. In so doing it promises to deliver the highest diagnostic yield with the least physician effort.

However, convenience and efficiency aside, the difference between this system and conventional ECG capture really lies in its diagnostic reliability. Conventional “state-of-the-art” positive predictive value (PPV) for detecting AFib is documented at around 59%, this being the percentage of true positive cases among total cases detected. Contrastingly the PPV for Cardiologs’ detection of AFib was 91%2 included in the cleared FDA submission. Also as included in the cleared FDA submission, Cardiologs’ sensitivity for detecting AFib was reported to be 97%3 (the percentage of positive cases truly identified) and was superior to “state-of-the-art” 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.”

The Cardiologs system is already CE-marked in Europe.

Physician comments

“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 Dr. Arnaud Rosier, cardiac electrophysiologist at the Hôpital Jacques Cartier, Massy. “Unfortunately, current R-R interval based methods to detect AFib are characterized by an inferior Positive Predictive Value (PPV) of under 59%, 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.”

Company comments

“Cardiologs is a game-changer for arrhythmia screening,” added Yann Fleureau, co-founder and CEO of Cardiologs Technologies. “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.

“Our Cardiologs team has trained a neural network using more than 500,000 recordings, and this training dataset keeps growing,” said Fleureau. “The result is that Cardiologs is designed to recognize patterns in a cardiac signal for fast and precise analysis of arrhythmias such as AFib in a similar intuitive manner as expert cardiologists. We especially bring the P-wave detection (atrial activity) to a whole new level, which explains our radically better PPV,” said Fleureau.

Source: Business Wire

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