US-based Vektor Medical has secured the CE mark for its non-invasive vMap System, designed to assist physicians in the treatment of individuals with arrhythmias.
The system utilises AI to convert data from a standard 12-lead electrocardiogram into three-dimensional maps that pinpoint the source of arrhythmias, such as ventricular tachycardia and atrial fibrillation, all within less than a minute.
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The certification was achieved through the British Standards Institution (BSI), in accordance with the EU Medical Device Regulation.
vMap is designed to integrate with existing technologies in medical laboratories, providing a solution that enhances clinical workflows and offers physicians an understanding of arrhythmia mechanisms.
Furthermore, it is said to amplify the pulsed field ablation (PFA) impact by offering electrophysiologists rapid insights into the ablation targets during the planning phase of the procedure and within the electrophysiology laboratory.
According to the company, the system, which had been exclusively used in the US before, has been employed across more than 30 hospitals.
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By GlobalDataVektor Medical CEO Rob Krummen said: “Securing CE Mark under the EU Medical Device Regulation, one of the most rigorous regulatory frameworks in the world, underscores the strength of our technology and quality systems.
“With regulatory approvals now in place in the US and Europe, we are well positioned to accelerate adoption and expand access to this innovation globally.”
In September 2025, the company announced the enrolment of the first subject in the VITAL-EP trial by Ascension St. Vincent’s, US.
This trial is tailored to assess the vMap-guided workflow optimisation and efficacy of ablation procedures.
It will assess various endpoints, as well as key efficiency measures like duration of the procedure and fluoroscopy usage.
The study, which includes retrospective as well as prospective cohorts, plans to enrol a total of 110 subjects across five sites.
Last year, the company secured $16m in Series A financing to further the expansion of vMap.
