Recall Of Medtronic Guidewire High-Risk Class I, FDA Says
Executive Summary
Medtronic’s Angiographic Guidewire Component, distributed since 2007, was recalled because the devices weren’t sterilized. It’s the company’s eighth class I recall this year.
You may also be interested in...
Medtronic Pulls HeartWare Devices After Higher Risk Of Death Compared To Abbott’s HeartMate 3
The company had issued two recalls in the past few months for the device due to recorded deaths and adverse events, but after further analyses has decided to pull it off the market altogether.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.