FDA clears low-noise electrophysiology recording technology
The FDA cleared a new electrophysiology recording technology designed to improve signal acquisition and accuracy of electrogram interpretation in the diagnosis and treatment of complex atrial arrythmias, CathVision announced.
The ECGenius EP Recording System includes EP recording technology and a proprietary hardware amplifier to acquire high-fidelity, low-noise, cardiac electrograms to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation, according to a press release from the company.
Conventional EP 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, according to the release.
"ECGenius is setting a new standard for EP recording technology by providing clean electrical activation signals even in the most complex arrhythmias,” Peter S. Spector, MD, professor of medicine and engineering and director of cardiac electrophysiology at the University of Vermont in Burlington, said in the release. " This makes it possible to observe even minor, but significant, signal modifications.”
Spector said 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,” Spector said.
ECGenius is an open platform that can be integrated into current hospital environments. The system also includes modern computer functionalities, real-time and review windows for simultaneous EP analyses and study configurations and requires minimal user training.
"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," Mads Matthiesen, CEO of CathVision, said in the release. "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."
CathVision is actively developing AI-based solutions that will be integrated into the system to facilitate electrogram interpretation and improve clinical decision support, the company stated in the release.