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Standards published for live case demonstrations involving medical devices

This article was originally published in Clinica

Executive Summary

Six cardiovascular societies from around the globe have issued a statement outlining the first-of-their-kind standards that medtech companies and institutions should consider while performing and broadcasting live case demonstrations at medical conferences. The statement appears in the October issue of HeartRhythm Journal and is accompanied by a companion article authored by the US FDA that explains the agency's role in regulating live demonstrations that involve the use of investigational devices on patients enrolled in clinical studies.

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