Sunday, July 01, 2018 1:42:21 PM
The company’s website for a long time has suggested they would be filing first with a 3d non-continuous mode to be followed (if they actually get approved) with an application for the continuous mode. This is not new at all and it’s also not just 2d. It’s not continuous.
If you believe the company has made progress on this tech then this isn’t necessarily a bad move. Image quality and radiation dose were two items on the list from the old 510k applications. If you don’t believe the company has the tech then this doesn’t really matter. For what it’s worth they have announced a partnership with a well known consulting house to work on the hardware verification, a group I looked into. They are the reaI deal. They also recently stated that the work has actually started so this is more than a random announcement of an agreement.
Anyway I suggest anyone following this company look at the piece I put in the intro information from the fda regarding cone beam ct and this will make sense. There is also good information out there, also from the fda, regarding recent radiation safety initiatives.
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