QUOTED. March 6, 2018. Mary Jensen.
Executive Summary
Check out what US FDA Neurological Devices Panel Chair Mary Jensen had to say about the biggest point of debate at a recent panel meeting that focused on clinical trial requirements for intracranial aneurysm devices.
"I think the biggest bone of contention here was, what do you do with small unruptured aneurysms? Do you include them in the trial?" – Mary Jensen, panel chair, FDA’s Neurological Devices Panel
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