Warning Letters And Close-Outs – April 2023
Executive Summary
The US FDA released four device-related warning letters in April, involving alleged regulatory violations from Abbott, North American Diagnostics, Medivance and Synovo. The agency also closed out a 2021 Medtronic warning letter.
You may also be interested in...
News We’re Watching: Potential Shockwave Sale, Medtronic Layoffs, Warning Letter For Abbott
This week, the US FDA announced the Class I recall of Fresenisu Kabi’s Ivenix Infusion System. Also: Successful trial results from Boston Scientific, Ancora partners with Egnite, and trade groups object to the Environmental Protective Agency’s proposed rules on ethylene oxide.
Insulin Pump Recall Leads To FDA Warning Letter For Medtronic
The missive reflects quality systems issues at the Northridge, CA headquarters of Medtronic’s diabetes division. Analysts are split on what the warning letter’s long-term impact may be.
Medtronic Lands Surprise Approval On Symplicity Spyral
The US FDA’s decision to allow Medtronic to market the Symplicity Spyral renal denervation (RDN) device sets up a rivalry in the RDN market, as the medtech giant’s offering will come up against ReCor’s Paradise system.