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Brain Trust Advises US FDA On Aneurysm Device Trials

To help figure out how intracranial aneurysm devices should be evaluated in clinical trials, US FDA brought together its Neurological Devices Advisory Panel. The experts answered questions ranging from safety and efficacy endpoints that should be taken into consideration to post-market study requirements.

Brain

US FDA convened a panel of experts March 1 to help it figure out how to review intracranial aneurysm devices. The panel recommended several endpoints device-makers should consider when trying to determine if devices are safe and effective in clinical trials.

The agency's Neurological Devices Panel heard from FDA, industry, clinicians and patients at the meeting in Gaithersburg, Md., on what...

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