Vektor Medical announced it received CE mark approval for its vMap artificial intelligence-powered arrhythmia mapping system.
The company’s vMap converts standard 12-lead ECG data into 3D maps of arrhythmia sources in less than a minute. San Diego–based Vektor Medical said the CE mark certification allows hospitals and electrophysiologists in the European Union to use vMap to support cardiac ablation planning and treatment.
Vektor Medical designed vMap to help identify arrhythmia drivers and guide procedures for conditions such as atrial fibrillation and ventricular tachycardia. It takes less than three minutes for a clinician to input case information, download and markup an ECG in the system and receive a 3D, interactive arrhythmia hot spot map visualizing both the inside and outside of the heart.
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“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, an electrophysiologist at 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.”
Vektor Medical won FDA clearance for the vMap ECG mapping system in November 2021. The company said vMap has since been used in more than 2,000 procedures at over 30 hospitals across the U.S.
“vMap has shown its impact in the U.S. as a meaningful advancement in arrhythmia care,” 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 U.S. and Europe, we’re well positioned to accelerate adoption and expand access to this innovation globally.”
The system can be used as a non-invasive standalone tool or as a complement to existing electrophysiology lab systems. The company said vMap may enhance new ablation methods, such as pulsed field ablation, by providing rapid, non-invasive insights into optimal ablation targets.
