News | EP Lab | May 04, 2022

CathVision Announces FDA Clearance of ECGenius EP Recording System

ECGenius sets a new standard for ECG signal detection, interpretation and therapy support

ECGenius sets a new standard for ECG signal detection, interpretation and therapy support

May 4, 2022 — CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the FDA 510(k) clearance of the ECGenius EP Recording System. ECGenius, the company’s innovative EP recording technology and proprietary hardware amplifier, acquires high-fidelity, low-noise, cardiac electrograms to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation (AF).

Conventional EP recording systems typically acquire noisy and artifact-ridden electrogram signals, preventing the accurate analysis and interpretation of those signals and severely limiting the ability of electrophysiologists to correctly diagnose and devise ablation strategies. ECGenius delivers a necessary evolution in the quality of ECG signal acquisition, the accuracy of electrogram interpretation and the advancement of therapy support.

“ECGenius is setting a new standard for EP recording technology by providing clean electrical activation signals even in the most complex arrhythmias. This makes it possible to observe even minor, but significant, signal modifications,” said Dr. Peter Spector, Professor of Medicine and Engineering, and Director of Cardiac Electrophysiology, University of Vermont, Burlington, Vermont. “The system achieves minimal baseline noise without using a notch filter, minimizing EGM distortion. This provides the ability to see very low voltage signals which are often blurred or completely undetectable by the filtering of traditional recording systems. ECGenius is an excellent new system that will provide physicians with higher quality information with which to treat their arrhythmia patients.”

ECGenius is an open platform that can be seamlessly integrated into current hospital environments. The system also includes modern computer functionalities, real-time and review windows for simultaneous EP analyses and study configurations, and requires minimal user training.

“Our mission is to put electrophysiologists in the best position to improve clinical outcomes, and the basis for electrophysiology is the quality of the cardiac electrograms,” said Mads Matthiesen, CEO, CathVision. “The ECGenius System offers clean, unfiltered signals, and by replacing existing conventional EP recording systems, we give physicians a new way of looking at electrograms without adding more equipment to their EP labs.”

Additionally, ECGenius’s exceptional signal quality enables the future inclusion of artificial intelligence algorithms. CathVision is actively developing AI-based solutions that will be integrated into the system to facilitate electrogram interpretation and provide electrophysiologists with unprecedented levels of analysis and clinical decision support.

ECGenius1 is commercially available in the United States.

For more information: www.cathvision.com

 

1Not approved for sale in the EU.


Related Content

Feature | EP Lab | By Vijay Kundekar

Arrhythmias can be described as irregular heart rhythms that are brought on by numerous factors, including heart damage ...

Home August 23, 2022
Home
News | EP Lab

May 24, 2022 — Attune Medical, a pioneering medical device company with a technology platform based on temperature ...

Home May 24, 2022
Home
News | EP Lab

April 27, 2022 – CathVision, a medical technology company developing innovative electrophysiology solutions designed to ...

Home April 27, 2022
Home
News | EP Lab

Royal Philips, a global leader in health technology, announced late-breaking results of a large-scale, real-world ...

Home April 12, 2022
Home
News | EP Lab

January 14, 2022 — Medtronic has entered into a definitive agreement to acquire Affera Inc., a Boston area-based ...

Home January 14, 2022
Home
News | EP Lab

January 13, 2022 — Abbott received U.S. Food and Drug Administration (FDA) clearance for the EnSite X EP System with ...

Home January 13, 2022
Home
News | EP Lab

January 7, 2022 — Khaldoun Tarakji, M.D., M.P.H., associate section head of cardiac electrophysiology at the Heart ...

Home January 07, 2022
Home
News | EP Lab

January 5, 2022 — Stereotaxis announced a recent publication in Frontiers in Cardiovascular Medicine titled “Atrial ...

Home January 05, 2022
Home
Feature | EP Lab

Children’s Hospital Los Angeles cardiologist Michael Silka, M.D., helped to pioneer the development of indications for ...

Home December 07, 2021
Home
News | EP Lab

November 22, 2021 — BioSig Technologies Inc., a medical technology company commercializing an innovative biomedical ...

Home November 22, 2021
Home
Subscribe Now