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News Breaks
December 6, 2012
19:02 EDTABMDAbiomed's Impella retains Class III status by the FDA
Abiomed announced that the FDA Circulatory System Devices Panel voted to retain Class III status for the temporary ventricular support devices within the non-roller type cardiopulmonary bypass blood pumps category, which includes Impella. The 515i Reclassification Panel's confirmation of this category of device as Class III devices is consistent with both the current Class III classification for these device types and as recommended in the FDA's briefing documents, released on December 3.
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April 15, 2014
08:05 EDTABMDAbiomed acquires exclusive license for Opsens' optical sensor technology
Abiomed announced its acquisition of an exclusive license from collaboration partner Opsens. Through this exclusive licensing agreement, which covers the use of certain optical sensor technology in the field of cardio-circulatory assist devices, Opsens' miniature optical pressure sensors will be integrated into the Impella heart pump catheters to help further automate the control and operation of the Impella device in the catheterization lab. This licensing agreement, which secures Abiomed's rights to the technology and gives Abiomed the right to manufacture the sensors, is a continuation of an initial collaboration, entered into between Opsens and Abiomed in 2010.

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