Vektor Medical Receives FDA 510(k) Clearance Adding Atrial Flutter Mapping, Enhanced Connectivity and New Integration Capabilities to Next-Generation vMap

Clearance Expands vMap’s Non-Invasive Mapping Capabilities with Direct ECG Data Streaming, Software-Only Deployment and 3D Model Import Tools

SAN DIEGO--(BUSINESS WIRE)--Vektor Medical, a medical technology company transforming cardiac arrhythmia care, today announced it has received FDA 510(k) clearance for its next-generation vMap^® technology. The clearance expands vMap’s non-invasive mapping capabilities with several major enhancements, including atrial flutter mapping, direct ECG and data streaming with electroanatomic mapping systems, 3D model import and visualization, conversion of vMap into a Software as a Medical Device (SaMD), and local and remote connectivity to support secure data exchange.

Atrial Flutter Mapping

With this clearance, vMap’s clinical use now includes non-invasive localization of potential arrhythmia sources associated with atrial flutter mechanisms. This new capability broadens the range of arrhythmias that can be addressed using vMap, enabling clinicians to evaluate both atrial and ventricular arrhythmias using a single, rapid, non-invasive mapping solution.

Direct ECG Streaming

Designed to support physicians throughout the arrhythmia care pathway, the updated vMap strengthens procedural interoperability between external electroanatomic mapping systems, ECG recording systems, and vMap’s rapid, non-invasive analysis tools. Direct ECG streaming enables seamless transfer of ECG signals into the vMap technology, reducing manual data handling and helping electrophysiologists transition more efficiently from ECG acquisition to arrhythmia analysis and clinical decision-making.

Software as a Medical Device

As an FDA-cleared Software as a Medical Device (SaMD), future clinical sites will be able to implement vMap without reliance on custom hardware. This flexibility is designed to enable broader adoption, easier scaling across health systems, and a stronger foundation for integration with future digital health partnerships.

“Receiving this new FDA clearance for our next-generation vMap is a major milestone for our product capabilities and reflects our continued focus on advancing vMap in ways that support EPs in their day-to-day work,” said Rob Krummen, Chief Executive Officer of Vektor Medical. “Connectivity is essential for scalability. By enabling more seamless data flow, we are helping EPs access arrhythmia insights faster to make informed decisions with greater confidence and support more efficient procedures, all of which contribute to better patient outcomes. We will begin rolling out the enhanced vMap technology to U.S. customers over the next several months extending the clinical and operational benefits of a more connected vMap.”

vMap is a non-invasive technology that receives standard 12-lead ECG data and processes it using proprietary algorithms to generate two-dimensional (2D) and three-dimensional (3D) cardiac maps. The technology helps physicians identify arrhythmias to be mapped, mark arrhythmic beats, and localize potential arrhythmia source locations across all four chambers of the heart in under a minute. vMap supports analysis of focal, reentrant, and fibrillatory arrhythmia mechanisms for a broad range of atrial and ventricular arrhythmias.

“This clearance represents another important milestone in integrating vMap more seamlessly into today’s connected EP ecosystem,” said Dr. Ben D’Souza, Associate Professor of Clinical Medicine, Section Chief, and Director of the Electrophysiology Laboratory. “By enabling ECG data to move more freely and reliably into the mapping environment — and expanding its use to include atrial flutter — this update has the potential to further streamline EP lab workflows and make non-invasive mapping accessible to an even broader range of clinicians and patients.”

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.