Replies to post #36115 on Grapefruit USA Inc (GPFT)

[Denunzio36]

Thanks Guru. Why is the FDA concerned with picture quality? My understanding is the FDA reviews products for safety purposes. The DViS needs to have a certain picture quality to be approved? Are they stepping over their bounds with concern over picture quality? Does the quality have to do anything with safety?

[mr_sano]

<<Since fluoroscopic images are used to take 2d picture (X , Y coordinate ) ....there is nothing which stops to measure distance as well of pixel inside 2d picture ,this way even 3d base map can be updated continuously.... ..


I don't think I get you here. Please explain. What you have said is that the 3d map is created on the first revolution(s) and the 2d images overlayed and updated on this map which is read from a look up table(created on the first pass?) DVIS updates the 2d images every sec. I get that...Now you saying the Z or 3d MAP gets updated during this process as well? Explain how that is done? Would you agree that this would be the major innovation of the device? If the 3d map is not updated along with the other 2d imagery then I think DVIS is just a fluoroscope with some added features like the Disneyland singing headstone analogy. What benefit this has for medical professionals is something open for discussion. If DVIS is processing with a completely new system and updateing a 3d construct in real time then the FDA is going to want much information here. I would think they would need some serious third party software testing and clinical testing as this new algorithm would need to demonstrated its capabilities across several modalities.