Getinge's financial target 2024-2028: Adjusted EPS growth of above 12% on average [Yahoo! Finance]
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GETINGE AB UNSP/ADR (GNGBY)
NASDAQ:AMEX Investor Relations:
getinge.com/int/about-us/investors
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Source: Yahoo! Finance
The target takes into account today's decisions (see below) that follow from the letter that the U.S. Food and Drug Administration (FDA) sent to healthcare providers in the US on May 8th In the letter from the U.S. FDA, there are no new field actions referred to, but healthcare providers are advised to transition from Getinge's Cardiosave Intra-Aortic Balloon Pump (IABP), Cardiohelp System, and HLS Sets Advanced to alternative products, and to continue using Getinge's products only if no other alternatives are available. Getinge is estimated to have a market share in the U.S. of over 60% for the mentioned products, which includes both hardware and consumables. "We take this very seriously and as a result of the U.S. FDA's letter, we have decided to immediately pause promotional activities of the Cardiohelp System and Cardiosave IABP in the U.S. until outstanding actions related to quality improvements have been addressed and approved. The sale of these hardware products will be li
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News
- FDA issues 510(k) clearance for Getinge's Talis +ACG software [Yahoo! Finance]Yahoo! Finance
- Getinge limits sale of heart devices in the US after FDA warning [Reuters]Reuters
- FDA Roundup: May 10, 2024 [Yahoo! Finance]Yahoo! Finance
- FDA issues warning on Getinge device amid quality concerns [Yahoo! Finance]Yahoo! Finance
- US FDA recommends healthcare providers switch from Getinge's heart devices [Reuters]Reuters