Grapefruit USA Inc (GPFT)

[IMGGorBust]

Perhaps I can help, Shaka, since my background is in dealing with the FDA.

A huge portion of the 510(k) applications the FDA reviews deal with improvements to existing technology based on changes to software to make a device faster or more efficient. The reason these applications all pass is because the FDA is not reviewing the software for SE. That's not the analysis. The analysis is whether the "intended use" of the new device and the predicate are SE and whether functionally they generate SE product; in our case images. In other words, are the devices intended to be used for substantially equivalent services and does the new device allow the medical provider to deliver the service as effectively.

There are literally thousands of devices already approved by the FDA intended to aid in diagnosis and to be used as visual aids in medical procedures. Hundreds more that do so by generating 3D diagnostic images. When intended use is established to be SE the inquiry then moves to whether the differences in software create any new safety issues, not whether the software is SE. So questioning whether the software is SE is not part of the equation.

It's all about intended use, functionality and safety. Dean's software is breakthrough not because it creates a brand new medical procedure. It's breakthrough because it dramatically increases the speed of an already existing medical procedure. So long as it's as safe as the existing procedure, actually it's safer because it's faster and reduces radiation exposure, then it passes.

Does that help?