Ann: Investor Presentation, page-3

I wouldn't read too much into that, could be that the readings were more reproducible for example. 510(k) submissions are all about comparison of CV's, range of valid readings etc to show that the device is substantially equivalent.
That has to be one of the best investor presentations IPD have published, despite the flat sales for the Qtr there is definitely a lot going on over the next 6 months. Seems like everyone is waiting for SOZO in order to drive uptake, along with the payor study. Be nice to get some positive CHF data in the mix as well!