FDA clears ECGenius high-fidelity, low-noise electrophysiology recording technology

The ECGenius system

CathVision has announced US Food and Drug Administration (FDA) 510(k) clearance of the ECGenius electrophysiology recording system. ECGenius acquires high-fidelity, low-noise, cardiac electrograms to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation (AF).

Conventional recording systems typically acquire noisy and artifact-ridden electrogram signals, preventing the accurate analysis and interpretation of those signals and severely limiting the ability of electrophysiologists to correctly diagnose and devise ablation strategies, CathVision said in a press release. ECGenius delivers a necessary evolution in the quality of ECG signal acquisition, the accuracy of electrogram interpretation and the advancement of therapy support.

“ECGenius is setting a new standard for EP recording technology by providing clean electrical activation signals even in the most complex arrhythmias. This makes it possible to observe even minor, but significant, signal modifications,” said Peter Spector (University of Vermont, Burlington, USA).

“The system achieves minimal baseline noise without using a notch filter, minimising EGM distortion. This provides the ability to see very low voltage signals which are often blurred or completely undetectable by the filtering of traditional recording systems. ECGenius is an excellent new system that will provide physicians with higher quality information with which to treat their arrhythmia patients.”

“Our mission is to put electrophysiologists in the best position to improve clinical outcomes, and the basis for electrophysiology is the quality of the cardiac electrograms,” said Mads Matthiesen, CEO, CathVision. “The ECGenius System offers clean, unfiltered signals, and by replacing existing conventional EP recording systems, we give physicians a new way of looking at electrograms without adding more equipment to their EP labs.”


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