FDA Urges Caution in Some Neurovascular Stent Use
US FDA has issued new guidelines to providers because some patients experienced strokes or died after being treated for unruptured brain aneurysms with some neurovascular stents.
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Global Device Approvals Snapshot: 14 May – 20 May 2019; FDA Approves Stryker’s Neuroform Atlas Stent
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, the US FDA approved Stryker’s Neuroform Atlas stent system to be used with embolization coils to treat wide-necked intracranial aneurysms.
In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the US FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.
The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.