CathVision's AI EP Recording System Gains FDA Clearance for Cardiac Ablation Success Measurement

 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^TM and Signal Complexity^TM algorithms. These algorithms are part of the CARDIALYTICS^TM suite of artificial intelligence-powered analytics integrated into the ECGenius System.¹ 

The ECGenius System is now the only 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.

"CathVision's technology has taken us back to our roots in cardiac electrophysiology and improved upon critical data that was vastly overlooked for many years," said Dr. Larry Chinitz, the Alvin Benjamin and Kenneth Coyle, Sr. Family Professor of Medicine and Cardiac Electrophysiology, and Director, Cardiac Electrophysiology and Heart Rhythm Center in the Department of Medicine, Leon H. Charney Division of Cardiology at NYU Langone. "With improved signal quality providing accurate and meaningful data, the integration of CARDIALYTICS' uniquely principled AI tools will continue CathVision's transformation of electrophysiology." 

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.

"Our mission has always been to put electrophysiologists in the best position to improve clinical outcomes. Incorporating AI-based analytics into the ECGenius System is another important demonstration of our unique ability to deliver on that mission and achieve groundbreaking milestones. With clinical enhancements exclusively available in our ECGenius System, we maintain our leadership position in equipping electrophysiologists with the technology necessary to elevate patient outcomes," said Mads Matthiesen, CEO, CathVision. "CathVision is poised for an exciting phase as we launch the ECGenius System with CARDIALYTICS and intensify our research endeavors to continue delivering innovative technology that simplifies processes."