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Home » FDA clears algorithms for measuring cardiac ablation success from CathVision

FDA clears algorithms for measuring cardiac ablation success from CathVision

August 16, 2023 By Sean Whooley

cathvision ECGenius system
The ECGenius system. [Image from CathVision]
CathVision announced that it received FDA clearance for its PVI Analyzer and Signal Complexity algorithms.

The algorithms, as part of the suite of AI-powered analytics, integrate into CathVision’s ECGenius system. ECGenius, an electrophysiology (EP) recording system for facilitating electrogram interpretation, helps physicians improve ablation outcomes. It delivers intelligent, automated analyses for complex atrial arrhythmia procedures by measuring the success of cardiac ablation.

Unlike traditional EP recording systems that capture signals affected by noise and artifact, CathVision says ECGenius delivers a necessary evolution in quality for ECG signal acquisition. It also enhances the accuracy of electrogram interpretation and the advancement of therapy support, according to a news release. The system’s intelligent, automated analyses can help physicians confirm the success of ablation efforts.

Copenhagen, Denmark-based CathVision designed PVI Analyzer as a signal-based AI algorithm. It can confirm PVI isolation status across multiple cardiac ablation modalities in complex arrhythmias like AFib. Signal Complexity helps physicians visualize and quantify AFib complexity parameters in patients with persistent AFib.

CathVision said it made the tools available to physicians using the ECGenius on a price-per-use basis.

“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,” said CathVision CEO Mads Matthiesen. “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.”

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: cathvision

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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