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Stryker Devices Get First-Line US FDA Go-Ahead For Stroke

Executive Summary

It’s a first-in-class indication for clot-retrieval devices that the firm gained in a 2011 acquisition.

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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 – 27 January

This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel. 

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