Aneurysm Devices In The Regulatory Spotlight: US FDA Panel Meeting Set For March
The agency scheduled a Neurological Devices Panel meeting for March 1 to consider appropriate clinical design and data expectations for intracranial aneurysm devices.
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FDA's Neurological Devices Panel says sponsors should be required to conduct randomized controlled trials for aneurysm treatment devices such as flow diverters and should only be allowed to use performance goal studies as a last resort to support approval.
At this year’s International Stroke Conference, manufacturers offered a glimpse of new and emerging technologies for both ischemic and hemorrhagic stroke. These neurointerventional devices are gaining momentum and driving growth in the market for stroke products, a largely un-penetrated market valued at more than $1 billion worldwide.
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.