Sam Brusco, Associate Editor05.04.22
Electrophysiology (EP) company CathVision has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its ECGenius EP recording system.
The EP recording tech and hardware amplifier acquires high-fidelity, low-noise, cardiac electrograms to help improve diagnosis and treatment of complex atrial arrhythmias, including AFib. Conventional EP systems usually acquire noisy and artifact-ridden electrogram signals, preventing accurate analysis and interpretation.
"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," Dr. Peter Spector, Professor of Medicine and Engineering, and Director of Cardiac Electrophysiology, University of Vermont told the press. "The system achieves minimal baseline noise without using a notch filter, minimizing 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."
The open platform can be integrated into current hospital environments. ECGenius includes modern computer functionalities, real-time and review windows for simultaneous EP analyses and study configurations, and requires minimal training.
The system’s signal quality enables future inclusion of artificial intelligence algorithms, which CathVision is actively developing to facilitate interpretation.
The EP recording tech and hardware amplifier acquires high-fidelity, low-noise, cardiac electrograms to help improve diagnosis and treatment of complex atrial arrhythmias, including AFib. Conventional EP systems usually acquire noisy and artifact-ridden electrogram signals, preventing accurate analysis and interpretation.
"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," Dr. Peter Spector, Professor of Medicine and Engineering, and Director of Cardiac Electrophysiology, University of Vermont told the press. "The system achieves minimal baseline noise without using a notch filter, minimizing 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."
The open platform can be integrated into current hospital environments. ECGenius includes modern computer functionalities, real-time and review windows for simultaneous EP analyses and study configurations, and requires minimal training.
The system’s signal quality enables future inclusion of artificial intelligence algorithms, which CathVision is actively developing to facilitate interpretation.