AI-powered cardiac mapping system gains an important approval
San Diego-based Vektor Medical has gained CE mark approval for the vMap System, which uses artificial intelligence (AI) to turn 12-lead electrocardiograms (ECGs) into 3D maps of the heart. The noninvasive technology was previously cleared by the U.S. Food and Drug Administration (FDA) back in 2021.
The vMap System provides accurate maps related to both focal- and fibrillation-type arrhythmias—all in less than a minute. It can target issues in all four chambers of the heart and was designed to assist clinicians with triage, planning or performing various cardiac procedures.
According to Vektor Medical, this additional approval ensures electrophysiologists in Europe will be able to take full advantage of pulsed field ablation technologies as they continue to gain momentum all over the world.
“vMap has shown its impact in the U.S. as a meaningful advancement in arrhythmia care,” Rob Krummen, CEO of Vektor Medical, said in a prepared statement. “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.”
“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,” added Lucas Boersma, MD, PhD, an electrophysiologist with St. Antonius Hospital in The Netherlands. “vMap is emerging as a simple, noninvasive 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.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.