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Latest From Getinge AB
Global medtechs had a big enough challenge with COVID-19 and its aftermath before the full-scale regional conflict in Ukraine added more uncertainty to the question of when market normality would return.
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.
- 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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