Thanks 1B
The relative line is below
The company is also working towards a submission to the US Food and Drug Administration (FDA) under the 510(k) process for premarket notification in the USA.
I'm not sure how old this statement is and whether it refers to Cardanal at all. The last announcement posted on the Intelliheart website (as opposed to IMI site) was Sep 2006.
It does show however that IMI will be all over this as I am sure that FDA approval is one of the keys to its success.
BW
waiting patiently, page-10
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