Grapefruit USA Inc (GPFT)

[BennyJ]

Answer: From the newsletter in August'08

Some have wondered why we haven't begun marketing the Dominion Vi Scanner under FDA IDE regulations. Doing this would not be in the best interest of the company as we would be locked into a process that could last many years and should only be considered as a last resort. Many medical device manufactures that have taken this path typically have done so only because their devices were so unique they had nothing on the market to compare substantial equivalence. Under IDE regulations the device being marketed cannot be sold, it cannot generate revenue for the medical facility or physician and can only be used on specific patients and used for specific procedures under stringent guidelines. By marketing the Dominion Vi Scanner under IDE we could not generate any income or profit for the company and only add substantial costs

If I have a few FDA 510K clearances under my belt already and the longest one took only 9 months, I wouldn't be looking for outside conultant to get clearance. 09' was totally dead in the water. There was no interactive process. Do some research in 08' and 09' radiation emitting devices cleared by FDA.
8 points:(actually I have more - no time. get into work)
1) FDA was very slow & cautious & reluctant in approving radiation emitting devices in 08' and 09' due to Media
2) Only Big Boys were approved. Not medium sized or small sized company.
3) There was no interactive process.
4) O-arm x-ray volumetric imaging was only approved which was not real time.
5) Real-time photo-flurography high resolution images - nobody is out there in the market.
6) mobile CT will be obsolute & o-arm volumetric x-ray imaging will be obsolute in the near future - Lot of big companies are already in the process of moving to photo-flurograpy volumetric imaging/ real time/high resolution.
7) IMGG only has patent on this.
8) IMGG will be bought out pretty soon after approval.