CathVision’s Algorithms to Measure Cardiac Ablation Success Earn FDA Nod

CathVision, a company developing electrophysiology (EP) solutions for clinical decision making in the EP lab, has earned U.S. Food and Drug Administration (FDA) clearance and launched its PVI Analyzer and Signal Complexity algorithms. These are part of the firm’s CARDIALYTICS suite of artificial intelligence (AI)-powered analytics in its ECGenius system.
 
According to CathVision, ECGenius is now the only EP system with an AI algorithm to assist with electrogram interpretation and deliver intelligent, automated analyses to help improve ablation outcomes in complex atrial arrythmia procedures by measuring cardiac ablation success.
 
The PVI Analyzer is a signal-based AI algorithm to confirm PVI isolation status across multiple cardiac ablation modalities when treating complex arrhythmias like AFib. The Signal Complexity algorithm helps visualize and quantify AFib complexity parameters in patients with persistent AFib.
 
The tools are available on the ECGenius system on a price-per-use basis. ECGenius leverages EP recording tech and a proprietary hardware amplifier that acquires high-fidelity, low-noise electrograms to help improve complex atrial arrythmia diagnosis and treatment.
 
“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,” 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, told the press. “With improved signal quality providing accurate and meaningful data, the integration of CARDIALYTICS’ uniquely principled AI tools will continue CathVision’s transformation of electrophysiology.” 
 
Traditional EP systems often capture electrogram signals marred by noise and artifact. According to the company, ECGenius is a necessary evolution in the quality of intracardiac and ECG signal acquisition, accuract of electrogram interpretation, and advancement of therapy support.
 
“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 of 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.”