Grapefruit USA Inc (GPFT)

[ws_guy]

Great Progress:

Todays news was in-fact the most important news from Imaging3 in years. A software validation/QA agreement with a highly reputable company like CriTech is a critical step forward to get 510K FDA approval. CriTech has 100% FDA approval track record, they are generally very careful while taking a project for FDA submission in order to maintain their reputation.
From the past rejections, the software QA was a major stumbling block for Imaging3. Although, Imaging3 must prove that, there are many predicate device as far as hardware is concern. From a hardware standpoint this device is not different from Medtronic O ARM or C ARM from other OEM's.
The KEY element was always a elusive piece of software. Now with the CriTech involvement, I am sure FDA will look into Imaging3 510K application differently.
Time will tell, but this could be one of those stories where BK company fights back and emerges as winner.

WS