US FDA clears Cardiologs ECG Analysis platform

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

Cardiologs’ platform is designed to aid physicians in screening for atrial fibrillation (AF) and other arrhythmias using long-term ambulatory electrocardiogram (ECG) monitoring recordings. The Cardiologs system is also CE marked in Europe.

“It is intuitive that screening for AF and subsequent anticoagulant treatment should reduce the stroke burden, which is the basis of guideline recommendations to screen for AF in people over the age of 65,” says Arnaud Rosier, cardiac electrophysiologist at the Hôpital Jacques Cartier, Massy, France. “Unfortunately, current RR interval based methods to detect AF are characterised 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.”

Conventional “state-of-the-art” PPV for detecting AF is less than 59%, according to a company release. The PPV for the Cardiologs system’s detection of AF was reported as 91% in the cleared FDA submission. In addition, the system’s sensitivity for detecting AF was reported to be 97%, again superior to “state-of-the-art” conventional methods of detecting AF and other arrhythmias, according to the release.

Cardiologs’ study results were published last year in the European Journal of Preventive Cardiology. The study’s investigators conclude, “This method may be more reliable and accurate than previous methods in the diagnosis of AF on long-duration ambulatory ECG and other monitoring devices.”

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