Arrhythmia monitors should be Class II devices subject to special controls -- Zymed petition.
This article was originally published in The Gray Sheet
Executive Summary
ARRHYTHMIA MONITOR DOWNCLASSIFICATION TO CLASS II WITH SPECIAL CONTROLS is called for by Zymed Medical Instrumentation in a July 30 petition to FDA. The Camarillo, California-based company bases its argument on the fact that the "algorithm core" used in its Central Station telemetry arrhythmia monitoring system is identical to that employed in other Zymed arrhythmia detection systems used to retrospectively review electrocardiograph data, which are regulated as Class II devices.