Just doing some reading and awhile ago there were some concerns (some would say ALOT of concerns) whether the Dvis fit into a predicate slot behind some other similar device.
Talk was that because this is so revolutionary that the FDA would have trouble ultimately matching it, and ultimately approving it for market.
read this from the link from the fda website I just posted earlier
"The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate."
will the Dvis BE THE STANDARD PREDICATE and that maybe is why this is taking so long because the template and fine tuning has to be set. this is a great thing to read.
News 
Market Data 
Discover 
