Getinge limits sale of heart devices in the US after FDA warning [Reuters]
GETINGE AB UNSP/ADR (GNGBY)
NASDAQ:AMEX Investor Relations:
getinge.com/int/about-us/investors
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Source: Reuters
Food and Drug Administration (FDA) to its devices. "We have decided to immediately pause promotional activities of the Cardiohelp System and Cardiosave Intra-Aortic Balloon Pump in the U.S. until outstanding actions related to quality improvements have been addressed and approved," said CEO Mattias Perjos in a statement. Getinge would limit sales of the two products in the U.S. to customers who had no available alternatives, it said. The company has to resolve quality problems with its heart pumps and with sterile packaging of products for heart-lung support systems, that have squeezed its margins and knocked its shares since the second quarter last year. It now targets over 12% growth on average in its adjusted earnings per share (EPS) for 2024-2028, the company said, compared to its previous target for over 10% growth in EPS for 2022-2025. Getinge said that until new products are approved and launched, its finances would be negatively affected, but that it was too early to
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News
- FDA issues 510(k) clearance for Getinge's Talis +ACG software [Yahoo! Finance]Yahoo! Finance
- Getinge's financial target 2024-2028: Adjusted EPS growth of above 12% on average [Yahoo! Finance]Yahoo! Finance
- 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