Grapefruit USA Inc (GPFT)

[ElHefe]

Interesting article. A couple of items of note:

- "It cannot say, 'this is questionable, so do such and such and show us the outcome'."
And yet that appears to be what FDA did when they told Dean to send images and go out and comparable images from predicate devices and, by the way, include a review by a radiologist.

-Is the DViS being reviewed by an expert scientific panel of consultants as the article suggests is the norm? Are they not FDA employees?