CDRH Explains Itself as Ethicon Prepares to Defend Its Sedasys

Devices & Diagnostics Letter
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As Johnson & Johnson (J&J) subsidiary Ethicon Endo-Surgery prepares to defend its computer-assisted personalized sedation system before an independent advisory panel convened by FDA Commissioner Margaret Hamburg, CDRH is finally explaining why it rejected the Sedasys device in the first place.

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