FDA Clears AI-Assisted EP Recording System for Measuring Cardiac Ablation Success

These algorithms are part of the CARDIALYTICS suite of artificial intelligence-powered analytics integrated into the ECGenius System.

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CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, announced the FDA clearance and commercial availability of the PVI Analyzer and Signal Complexity algorithms. These algorithms are part of the CARDIALYTICS suite of artificial intelligence-powered analytics integrated into the ECGenius System.

The ECGenius System is an EP recording system with an AI algorithm to facilitate electrogram interpretation and deliver unprecedented levels of intelligent, automated analyses designed to help physicians improve ablation outcomes in complex atrial arrhythmia procedures by measuring the success of cardiac ablation. The CARDIALYTICS suite includes:

  • PVI Analyzer: a signal-based AI algorithm capable of confirming PVI isolation status across multiple cardiac ablation modalities when physicians treat complex arrhythmias such as atrial fibrillation.
  • Signal Complexity: an algorithm to help physicians visualize and quantify atrial fibrillation (AF) complexity parameters in patients with persistent AF.

These unique tools are available to physicians using the ECGenius System on a price-per-use basis.

ECGenius System is CathVision's innovative EP recording technology and proprietary hardware amplifier that acquires high-fidelity, low-noise cardiac electrograms to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including AF. Unlike traditional EP recording systems that often capture electrogram signals marred by noise and artifact, ECGenius delivers a necessary evolution in the quality of intracardiac and ECG signal acquisition, the accuracy of electrogram interpretation, and the advancement of therapy support. With exceptional data from the ECGenius System, intelligent automated analyses can effectively enable physicians to confirm the success of ablation efforts.

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