US FDA issues 510(K) clearance to Activaero

Published: 9-Dec-2009

The US Food and Drug Administration (FDA) has issued 510(K) clearance to Activaero's Akita Jet inhalation system.


The US Food and Drug Administration (FDA) has issued 510(K) clearance to Activaero's Akita Jet inhalation system.

Activaero, a German designer of controlled breathing drug delivery technologies with offices in Germany and the US, says the clearance, while for general purpose use, helps pave the way for the company to use the Akita Jet in clinical trials to develop combination products in the US.

In 2007, Activaero received 510(K) clearance for the Akita Apixneb inhalation device, which is currently in clinical trials for a variety of new therapies.

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