From the conference call I think they had 1 request for information on something? If I heard that right?
The FDA clearance in my limited understanding is not for a completely new product or drug etc. This takes much longer and there is way more uncertainty around that type of thing.
This is for a product that is just like many others already in the market including the US markets. In fact in use all around the world every day.
Unless they are using some weird way to perform a scan I really don't know why they wouldn't get FDA clearance? Just a matter of time I think. The MD in the conference call didn't think it would be a problem from memory.
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