What we can do is distribute the device into a clinical environment and use it on patients with their consent as well as other rules. This is not a PMA or other required step, it is actually a good step towards approval and hasn't changed our 510(k) status at all, it just moves us forward.
As to other comments, I cannot say whether we are at whatever percentage through the process as I don't control that, the FDA does. You can infer that they most likely wouldn't allow the Dominion to be used on patients if they felt uncomfortable with the technology or product as a whole.
Dean
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