Meridian on track with US marketing plans:
This article was originally published in Clinica
Executive Summary
Meridian Medical Technologies says it is on track to submit a 510(k) marketing application to the US FDA for its Prime ECG electrocardiac mapping system by the end of July. The device records ECG data from the entire torso, which the Columbia, Maryland firm claims, provides substantially more information than is possible with a traditional 12-lead ECG. The product, which incorporates a patented disposable electrode vest, is already approved for sale in Europe.