Cardiologs wins FDA 510(k) for ECG analysis platform

Cardiologs Technologies said today it won FDA 510(k) clearance for its Cardiologs ECG analysis platform designed to aid in the screening for atrial fibrillation and other arrhythmias.

The platform is a cloud-based cardiac monitoring and analysis web service which uses artificial intelligence to analyze long-term ambulatory ECG monitoring recordings, the Paris-based company said. The system already has CE Mark approval in the European Union, the company added.

“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. Unfortunately, current R-R interval based methods to detect AFib are characterized by an inferior Positive Predictive Value 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,” Dr. Arnaud Rosier of the Hôpital Jacques Cartier said in a prepared statement.

“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. Our Cardiologs team has trained a neural network using more than 500,000 recordings, and this training dataset keeps growing. 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 to a whole new level, which explains our radically better PPV,” co-founder & CEO Yann Fleureau said in a press release.

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