CathVision has gained the CE Mark certification for its ECGenius system, enabling the company to market and distribute the system throughout the European Economic Area.
The certification indicates that the ECGenius System complies with the stringent requirements of the European Medical Device Regulation (MDR), ensuring adherence to safety, health, and environmental protection standards.
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Tailored to deliver real-time and “accurate” electrogram recording, powered by signal processing and AI-driven analytics, the system has already secured 510(k) clearance from the US Food and Drug Administration (FDA).
The company is set to begin commercialisation in Europe in the upcoming quarters, building on its current US customer base.
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.”
The system is recognised for its ability to acquire “high-fidelity”, and “low noise” electrophysiology (EP) signals, offering a distinct advantage in signal quality.
This quality is crucial for physicians in diagnosing and treating complex cardiac arrhythmias.
CathVision’s technology is particularly adept at offering visibility of low-voltage EGMs, allowing for the “visualisation” of small pathway potentials, scar tissue, or HIS signals that may be obscured by baseline noise in other market-leading recording systems.
The ECGenius system’s patented amplifier design is integral to its hardware technology and software, enabling the acquisition and recording of clinical data with precision.
CathVision was founded in 2013 and headquartered in Denmark, with a US office in Minnesota. The company focuses on developing electrophysiology solutions to enable physicians with cardiac electrical signals, aiding in the diagnosis, characterisation, and treatment of heart rhythm disorders.
In April 2022, CathVision concluded subject enrolment in the US trial of the ECGenius system.
