Vektor Medical, based in San Diego, said it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s computational ECG mapping system, vMap, which is designed to map potential arrhythmia sources (hot spots) associated with stable or unstable arrhythmias
The device can detect the arrhythmia sources anywhere in the heart — including all four chambers, the septal wall, and the outflow tracts — in less than three minutes using ECG data.
The vMap system will be commercially available to sites across the U.S.
The system takes less than three minutes for a clinician to input case information, download and markup an ECG in the system, and receive a three-dimensional, interactive arrhythmia hot spot map visualizing the inside and outside of the heart. vMap can be used as a non-invasive standalone tool or as a complement to traditional invasive electro-anatomical mapping systems in planning and procedural settings.