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Aus Systems gets FDA approval

Microscopy Australia testing services enabled Aus Systems to get approval to export their innovative medical device – a disposable rectal biopsy system.

The company needed to show that different sterilisation procedures didn’t change the structure of the plastic components.

The Microscopy Australia ToF-SIMS Flagship instrument at University of South Australia was used to show that the structure of the plastic did not change. These results led directly to FDA approval. Aus Systems now exports the devices to the USA from their manufacturing base in Adelaide.


August 15, 2009