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Aneurysm Devices In The Regulatory Spotlight: US FDA Panel Meeting Set For March

 
• By David Filmore

The agency scheduled a Neurological Devices Panel meeting for March 1 to consider appropriate clinical design and data expectations for intracranial aneurysm devices.

Medical devices to treat intracranial aneurysms will get attention by a panel convened by US FDA on March 1. The agency's Neurological Devices Panel will meet then to discuss clinical requirements for this class of devices, FDA said in a Dec. 27 meeting notice.

Multiple companies are developing interventional devices to treat aneurysms and hemorrhagic stroke, with some products, including Medtronic PLC's Pipeline...

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More from Policy & Regulation

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• By Ashley Yeo

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
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