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Sunday, February 01, 2009 6:21:41 PM
Yes, CT is an aspect of our 510k which is adding to the delay of our approval for now. Nothing really over the top, we just have to be careful from this point forward, especially in a new political environment and the latest bashing the FDA has received in the media.
We are not concerned, nor do we think the O-arm is a direct competitor as they have a narrow market focus, a crazy high price and their own system issues. Since the O-arm opens up it has had problems getting stuck in the closed position, I'm told this has happened more than once with a patient on the table.
Dean
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