San Diego — Vektor Medical has received FDA 510(k) clearance for its next-generation vMap technology, adding new features including atrial flutter mapping, direct ECG data streaming, 3D model import capabilities, enhanced integration with electroanatomic mapping systems, and deployment as a Software as a Medical Device (SaMD). The clearance also enables both local and remote connectivity to support secure data exchange across clinical environments.
“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.
With this clearance, vMap can now be used for non-invasive localization of arrhythmia sources associated with atrial flutter mechanisms. This expands the tool’s clinical scope beyond ventricular arrhythmias, allowing clinicians to evaluate both atrial and ventricular arrhythmias using a single, rapid, non-invasive mapping solution.
The upgraded technology also introduces direct ECG streaming, strengthening interoperability between external electroanatomic mapping systems, ECG recording systems, and vMap’s analysis tools. Seamless ECG data transfer reduces manual data handling and helps electrophysiologists move more efficiently from ECG acquisition to arrhythmia analysis and treatment planning.
As an FDA-cleared SaMD, vMap can now be deployed at clinical sites without reliance on custom hardware. This flexibility is intended to simplify adoption and scaling across health systems while supporting deeper integration with future digital health partnerships.
“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,” Krummen added. The company expects to begin rolling out the enhanced vMap platform to U.S. customers over the coming months.
vMap uses proprietary algorithms to process standard 12-lead ECG data and generate two-dimensional and three-dimensional cardiac maps. The system helps physicians identify arrhythmias to be mapped, mark arrhythmic beats, and localize potential arrhythmia sources across all four chambers of the heart in under a minute. The technology supports analysis of focal, reentrant, and fibrillatory 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 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.”
