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CONTINUOUS PATIENT MONITORING SYSTEMS, INTERPRETIVE ECGS AND AUTOMATED EXTERNAL DEFIBRILLATORS SHOULD BE DOWNCLASSIFIED, HIMA SAYS

This article was originally published in The Gray Sheet

Executive Summary

Arrhythmia monitor and alarm devices incorporating arrhythmia detection algorithms should be reclassified to Class II, the Health Industry Manufacturers Association maintains in an Aug. 14 petition. Special controls to regulate the devices should include performance testing against manufacturers' waveform databases, HIMA says.

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