VDI Technologies Achieves CE Mark

VDI Technologies, a leading innovator in ultra-high frequency electrocardiography (UHF-ECG), has announced that its groundbreaking VDI UHF-ECG has received CE mark certification under the European Union Medical Device Regulation (MDR). This certification affirms that the device complies with the highest EU standards for safety, health, and environmental protection, paving the way for its clinical deployment across Europe. Obtaining certification in mid-2025 enabled the sale of clinical devices that can be fully utilized for patient diagnosis and therapy optimization.

The VDI UHF-ECG is a revolutionary diagnostic platform that leverages ultra-high-frequency ECG signal analysis to deliver unparalleled insights into cardiac electrical activation. Developed in collaboration with leading cardiologists and biomedical engineers, the solution offers a novel window into the microstructure of ventricular activation, enabling early and more precise identification of conduction system disorders.

Achieving CE mark certification is a significant milestone for our team. The VDI UHF-ECG represents a leap forward in non-invasive cardiac diagnostics, enabling clinicians to assess patients at risk of heart failure or complex arrhythmias with new levels of precision.

Unlike conventional ECG technologies that analyze signals up to 100 Hz, the VDI UHF-ECG processes signals up to 1,000 Hz, uncovering subtle electrical patterns previously hidden within the standard bandwidth. Clinical studies have demonstrated the solution’s ability to enhance localization of pathological substrates in patients with ventricular tachycardia and improve pre-procedural planning for catheter ablation.

With the CE mark in place, VDI Technologies is now poised to expand access to the VDI UHF-ECG across hospitals and research centers throughout the EU and beyond. The company continues to work with clinicians and academic partners to explore further applications of UHF-ECG in cardiology and related disciplines.

For more information, visit www.vdimaging.com.