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June 3, 2014
08:12 EDTABMDAbiomed surpasses 20,000 U.S. Impella patients
Abiomed reported that physicians have implanted more than 20,000 Impella pumps in U.S. patients requiring hemodynamic support. To date, the higher flow Impella CP has been implanted in over 3,000 U.S. patients, the company noted. The Impella RP recently received CE Marking approval in the European Union and also completed patient enrollment in its Investigational Device Exemption trial, RECOVER RIGHT, with an extended Continuous Access Protocol to allow the company to continue enrolling an additional 22 patients into the trial for further evaluation. FDA approval for the Impella RP is expected by early 2015, Abiomed said.
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June 29, 2015
12:14 EDTABMDAbiomed says DOJ closes investigation into Impella 2.5
Abiomed announced that it has received confirmation from the United States Department of Justice that it has closed its investigation into the company’s marketing of the Impella 2.5 device without taking enforcement action. “We are pleased that the Department of Justice has chosen to close its investigation without pursuing any further action and that this matter is now behind us. We have always remained steadfast in our integrity and our commitment to putting our patients first,” said Abiomed CEO Michael Minogue.

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