Crunch Time, page-25

FDA approval was over a blackbox manually plate fed device where plates went in results came out.  It was an approval of the algorithm, not an automatically fed comercial device that customers would by.  This was BBs answer to a previous question.  He also acknowledged as part of that answer that LBT might have had difficulty explainng this to the market. I think this is an import mature realisation on BBs part.

Wisplinghoff apparently going through same process as St Vincent's and publishing findings.

Distributors won't put their name to a device until it is proven to be a slam dunk (bastards!). Therefore LBT through CCS have to get the device in end customers hands to force the hands of the distributors.