Vektor Medical, a San Diego–headquartered medical technology company focused on advancing arrhythmia diagnosis and treatment, has received US Food and Drug Administration 510(k) clearance for its next-generation vMap technology.

The clearance significantly expands vMap’s non-invasive cardiac mapping capabilities, adding atrial flutter mapping, direct ECG and data streaming with electroanatomic mapping systems, 3D model import and visualization, and enhanced local and remote connectivity for secure data exchange. The update also transitions vMap into a Software as a Medical Device, enabling deployment without the need for custom hardware.

With the new clearance, vMap can now non-invasively localize potential arrhythmia sources associated with atrial flutter, broadening its clinical scope beyond ventricular arrhythmias. Physicians can now assess both atrial and ventricular arrhythmias using a single, rapid, non-invasive mapping platform.

The upgraded system is designed to support clinicians across the arrhythmia care pathway by improving interoperability between ECG recording systems, external electroanatomic mapping platforms, and vMap’s analytical tools. Direct ECG streaming allows real-time transfer of signals into vMap, reducing manual data handling and helping electrophysiologists move more efficiently from ECG acquisition to clinical decision-making.

As a US Food and Drug Administration-cleared Software as a Medical Device, vMap offers greater flexibility for hospitals and clinics, supporting easier implementation, broader scalability across health systems, and future integration with digital health platforms.

Rob Krummen, Chief Executive Officer of Vektor Medical, said the clearance represents a major milestone in expanding vMap’s clinical and operational value. He noted that improved connectivity and data flow will help electrophysiologists access actionable arrhythmia insights faster, supporting more efficient procedures and improved patient outcomes. The company plans to roll out the enhanced vMap technology to US customers over the coming months.

vMap is a non-invasive technology that processes standard 12-lead ECG data using proprietary algorithms to generate two-dimensional and three-dimensional cardiac maps. In under a minute, the system helps clinicians identify arrhythmic beats and localize potential arrhythmia source locations across all four chambers of the heart, supporting analysis of focal, reentrant, and fibrillatory arrhythmias.

Dr. Ben D’Souza, Associate Professor of Clinical Medicine and Director of the Electrophysiology Laboratory, said the expanded capabilities and improved data integration could further streamline electrophysiology lab workflows and make non-invasive mapping accessible to a wider range of clinicians and patients.

Vektor Medical stated that vMap remains the only US Food and Drug Administration-cleared non-invasive technology using standard 12-lead ECG data to localize arrhythmia sources across all four cardiac chambers, helping physicians identify arrhythmia drivers more quickly and accurately.