Grapefruit USA Inc (GPFT)

[eagleagain2002]

Imaging3’s CEO, Dean Janes, today provided insight into the Company’s strategy for resubmission to the FDA.



“After reviewing with our FDA counsel our prior application, files, images and recent FDA correspondence, Imaging3 plans to resubmit its application for clearance of the Dominion Vi Scanner under the FDA's 510(k) process,” stated Dean Janes, Chairman and CEO of Imaging3, Inc. According to Mr. Janes, “the results of our review with counsel has determined that the 510(k) program remains the most appropriate and efficient route for FDA approval. It was determined that the “De Novo” and “PMA” processes were not necessary and with some minor adjustments to our existing package along with some additional information and potentially a pre-submission meeting with the FDA, the 510(k) submission should be successful. I am confident that with the assistance of our newly hired FDA consultants and our new strategy we will be able to provide the Agency with a package that meets their needs to expeditiously approve our device,” Mr. Janes added.



If you have any questions, please contact Investor Relations by e-mail or by calling [phone] [phone]



Sincerely,

Investor Relations
Imaging3, Inc.
Burbank CA 91505