Stryker Devices Get First-Line US FDA Go-Ahead For Stroke
It’s a first-in-class indication for clot-retrieval devices that the firm gained in a 2011 acquisition.
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FDA: Marketing Materials Encouraged Neurovascular Catheter Misuse
Some manufacturers may be suggesting their guide catheters can be used to remove thrombus – an off-label use that could cause hemorrhage and other adverse events, FDA says.
Stryker Buys Concentric Medical To Enter Acute Ischemic Stroke Market
Stryker will gain access to the acute ischemic stroke market by acquiring privately held Concentric Medical for $135 million under a definitive agreement announced Aug. 31.
News We’re Watching: Disease X Act, Abiomed Recall, TAVR AI Cleared
This week, the bipartisan Disease X Act for pandemic preparedness was introduced in the US House of Representatives; Abiomed Impella pumps were the subject of a class I recall; Dasi Simulations and Endologix landed FDA clearances; and the FDA warned against the use of Getinge/Maquet Oxygenators.