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Latest From Getinge AB
The US FDA has updated a recall of Datascope Cardiosave IABPs to reflect its class I high-risk status and announced a recall of the labeling for Abiomed’s Impella RP Flex.
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.
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.
Medtech Insight’s just-published ranking of the leading global medtechs based on revenues reported for fiscal 2021 reveals a picture of an industry overwhelmingly in growth, despite – or in some cases because of – the persistent effects of the pandemic.
- Implantable Devices
- Infection Control-Sterilization
Surgical Equipment & Devices
- Minimally or Less Invasive
- Other Names / Subsidiaries
- Atrium Medical Corp.
- Datascope Corporation
- Getinge Group
- Getinge GmBH
- InterVascular SAS
- InterVascular Inc.
- Maquet Getinge
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