Ann: Update on US FDA De Novo Classification Request, page-218

You can argue with me till you're blue in the face. But I can show you the reality of it. I posted this chart (below Post #: 42957188 ) with a warning last time but the ra(m)pers shot me down. The caution was there, the facts are there, the FDA are not comfortable with this. You want it to work because you wanna make money. the FDA (and me) don't want a device to misdiagnose they want a thoughtful doctor to do their best. i agree totally.

And now the end of today's chart.



looks like history repeats huh?


now with the Sleep apnea, it is already done via machines to diagnose, so i feel more comfortable and feel this is more realistic. Call me old fashioned, (although still under 50) but i am confident that the resapp will not be used anytime in the near future.

Again, call me what you like, argue your case, but my case is pretty bullet proof.

Question - Who wants it? Ann - Currently nobody that has tested it. Sounds bad when you look at it like that, doesn't it?