Danish medical technology company CathVision has announced the US Food and Drug Administration (FDA) approval and commercial roll-out of its PVI Analyzer and Signal Complexity algorithms.

The two new algorithms are part of the company’s Cardialytics suite of artificial intelligence (AI) powered analytics integrated into its ECGenius System.

PVI Analyzer is a signal-based AI algorithm that can confirm PVI isolation status across multiple cardiac ablation modalities when physicians treat complex arrhythmias such as atrial fibrillation.

Signal Complexity is an algorithm designed to help physicians visualise and quantify atrial fibrillation (AF) complexity parameters in patients with persistent AF.

CathVision is offering two new algorithms to physicians using the ECGenius System.

ECGenius System is the company’s advanced EP recording technology and hardware amplifier that acquires high-fidelity, low-noise cardiac electrograms.

CathVision CEO Mads Matthiesen said: “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.

“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.”

According to the company, traditional EP recording systems often capture electrogram signals marred by noise and artifact.

Its ECGenius delivers accuracy of electrogram interpretation, which is essential for the quality of intracardiac and ECG signal acquisition and 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.

The ECGenius System is the only AI-powered EP recording system to help interpret the electrograms and deliver high levels of intelligent, automated analyses.

It is designed to help physicians improve ablation outcomes in complex atrial arrhythmia procedures by measuring the success of cardiac ablation, said the medical device company.