Standards published for live case demonstrations involving medical devices
This article was originally published in RAJ Devices
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 conferences1,2. The statement appears in the October issue of HeartRhythm Journal and is accompanied by a companion article authored by the US Food and Drug Administration that explains the agency's role in the regulation of live demonstrations involving the use of investigational devices on patients enrolled in clinical studies3.
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