Vektor Medical Receives FDA’s 510(k) Clearance for Its ECG Mapping System, vMap

Vektor Medical has received the FDA’s 510(k) clearance for its computational ECG mapping system, vMap.

The system is designed to map potential arrhythmia sources (hot spots) associated with stable or unstable arrhythmias anywhere in the heart — including all four chambers, the septal wall and the outflow tracts — according to the San Diego, Calif.-based company.

A clinician can input case information, download and mark up an ECG in the system in less than three minutes, using only ECG data and receive a three-dimensional, interactive arrhythmia hot- spot map visualizing the inside and outside of the heart. The intention is to improve outcomes in ablation procedures. vMap can be used as a noninvasive standalone tool or as a complement to traditional invasive electro-anatomical mapping systems in planning and procedural settings, the company says.