SAN DIEGO: #Medtech--Vektor Medical, a medical technology company transforming cardiac arrhythmia care, announced it has received CE Mark for the vMap® System, a non-invasive tool developed with AI that transforms standard 12-lead ECG data into 3D arrhythmia source maps in under a minute.

vMap was invented to help physicians improve ablation outcomes for patients suffering from arrhythmias, such as atrial fibrillation and ventricular tachycardia. Use of vMap has also been associated with reductions in total procedure time. Previously available only in the United States, vMap has been successfully used in more than 2,000 procedures at more than 30 hospitals.

Securing CE Mark creates the opportunity for hospitals and electrophysiologists (EPs) across the European Union (EU) to access a new level of data-driven insights for arrhythmia care. As pressure mounts to improve outcomes and deliver value-based care, vMap provides a rapid, non-invasive way to identify potential arrhythmia drivers and guide treatment. Designed to complement existing lab technologies, vMap offers a scalable solution that fits seamlessly into clinical workflows, offering physicians added insight into arrhythmia drivers.

Vektor achieved CE Mark certification through BSI, its Notified Body, under the EU Medical Device Regulation. BSI provides extensive expertise in standards, Assurance, Regulatory, and Consulting services to help bring compliant products to market efficiently.

“Electrophysiology labs across Europe are in need of cost-effective ways to improve outcomes of ablation, especially in patients with more complex forms of atrial fibrillation,” said Dr. Lucas Boersma, electrophysiologist, St. Antonius Hospital Nieuwegein. “vMap is emerging as a simple, non-invasive way to gain critical insights upfront and during procedures, supporting more efficient workflows and informed decision-making. By helping clinicians target arrhythmia sources more accurately and optimizing lab time, it has potential to improve outcomes whilst also enhancing the impact of other new approaches like pulsed field ablation. It’s exciting to see this technology now available in Europe.”

The CE Mark milestone arrives at a pivotal moment in healthcare advancement, as the commercialization and adoption of pulsed field ablation (PFA) are rapidly accelerating. vMap enhances the impact of PFA by giving EPs fast, iterative insights into optimal ablation targets during pre-procedure planning and in the EP lab.

“vMap has shown its impact in the U.S. as a meaningful advancement in arrhythmia care,” said Rob Krummen, CEO of Vektor Medical. “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 U.S. and Europe, we’re well positioned to accelerate adoption and expand access to this innovation globally.”

To learn more about Vektor Medical, vMap technology, or to request a clinical or strategic briefing, visit www.vektormedical.com and connect with us on LinkedIn and X.

About Vektor Medical

Headquartered in San Diego, Vektor Medical is redefining how arrhythmias are understood and treated. The company developed vMap®, the only FDA-cleared, non-invasive technology that uses standard 12-lead ECG data to localize arrhythmia source locations across all four chambers of the heart. By helping physicians identify arrhythmia drivers more quickly and with greater accuracy, Vektor is improving outcomes, enhancing efficiencies, and accelerating access to effective treatment strategies. To learn more, visit www.vektormedical.com.

Fonte: Business Wire