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.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.
The document waives the annual registration fee for companies with gross sales below $1m that are currently going through bankruptcy.