Denmark-based medical technology company CathVision has received CE mark approval for its advanced electrophysiology solution, ECGenius System.
With the regulatory approval, CathVision is allowed to market and distribute the ECGenius System to healthcare providers and patients across the European Economic Area (EEA).
ECGenius System is an advanced medical device designed to acquire high-fidelity, low-noise EP signals to provide accurate and real-time electrogram recording.
It uses advanced signal processing and AI-driven analytics to provide actionable insights that help physicians identify, diagnose, and treat complex cardiac arrhythmias.
The system has already been granted the US Food and Drug Administration (FDA) 510(k) approval to improve the diagnosis and treatment of complex atrial arrhythmias.
CathVision CEO Mads Matthiesen said: “We are thrilled to achieve CE Mark certification for ECGenius System, which underscores our commitment to delivering high-quality, innovative medical technologies.
“This milestone not only validates the safety and efficacy of our device but also represents a significant step toward deploying our product worldwide.”
According to the company, conventional EP recording systems usually acquire noisy and artefact-ridden electrogram signals, which are challenging for analysis and interpretation.
Its ECGenius system delivers signals with minimal baseline noise, allowing physicians to visualise the cardiac signals accurately.
The system allows visualisation of small pathway potentials and scar tissue, which can be blurred or undetectable because of baseline noise in recording systems.
ECGenius System acquires clean signals without the need for a notch filter, decreasing the amount of EGM distortion related to notch filtration on traditional systems.
It features unique hardware technology and advanced software to acquire and record clinical data through a patented amplifier design.
The CE Mark certification indicates that ECGenius System meets the regulatory requirements of the European Medical Device Regulation (MDR).
Also, the system complies with health, safety, and environmental protection standards.
Building on the CE mark certification, CathVision plans to start commercialising the electrophysiology device in the European market in the coming quarters.
