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Device Week – March 14, 2016

This article was originally published in The Gray Sheet

Executive Summary

On this week's podcast, The Gray Sheet team discusses recent actions in the Senate HELP Committee, including committee passage of a breakthrough device bill. We also talk about the case of a novel fecal-incontinence device, which gained unanimous support from an FDA panel just days before the parent company announced plans to shut down the unit that makes the device, and we look at device cybersecurity in the Europe versus the US.

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