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05/18/13 7:10 PM

#30188 RE: kidnova #30186

They did not get 'scolded' by FDA. I work in industry and I've seen a few scoldings in my day..and that blurb wasn't one of them. Not even close.

The point of the meeting was for non-thermal devices, not thermal. Nothing they did could have helped them in the meeting - their device is (I guess) considered thermal (at this point). That's what the summary basically stated. It's out of scope.

They have no stake in the decision on Tuesday, whichever way it goes.

Their devices, if they ever are cleared, would need to be IMJ OTC, thermal.

From the looks of the summary, I don't think any of the non-thermal devices are going to get re-classed.