News We're Watching: Renal Denervation Trial Highlights, TAP Pilot Update, Cardiohelp Safety Alert
Two new studies support ReCor’s Radiance Ultrasound Renal Denervation System, and renal denervation also won the backing of European medical societies. Additionally, the FDA issued an update on the Total Product Life Cycle Advisory Program (TAP) “soft” pilot, and a disposable component of the Getinge/Maquet Cardiohelp system was flagged for possible sterility issues.
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Medtech Insight spoke to the president of Medtronic’s diabetes business, Que Dallara, as well as two of the company’s medical affairs directors, about the company’s recently published data, and the timeline for the US launch of its 780G system.
Class I Recall Of Datascope Cardiac Assist Devices
The US Food and Drug Administration has designated a recall of Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps from Datascope/Getinge as class I due to the potential for the pumps to shut down during use.
FDA Begins ‘Soft’ TAP, Will Phase In Pilot Over Five Years
The US Food and Drug Administration has rolled out a program designed to speed up the development of innovative medical devices. The Total Product Lifecycle Advisory Program pilot was authorized under MDUFA V.