BURBANK, CA--(Marketwire - November 29, 2010) -
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Imaging3™, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, 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.
About Imaging3
Imaging3, Inc., founded in 1993, is a leading provider of advanced technology medical imaging devices. The Company has developed a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time. Because these 3D images are instantly constructed in real-time, they can be used for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body. Visit the company’s website at www.imaging3.com
Safe Harbor Statement
Matters discussed in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this press release, the words “anticipate,” “believe,” “estimate,” “may,” “intend,” “expect” and similar expressions identify such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the expectations of the Company and are subject to a number of risks and uncertainties. These include, but are not limited to, risks and uncertainties associated with: the impact of economic, competitive and other factors affecting the Company and its operations, markets, product, and distributor performance, the impact on the national and local economies resulting from terrorist actions, and U.S. actions subsequently; and other factors detailed in reports filed by the Company.
Contact:
Imaging3, Inc.
Investor Relations
(800) 900-9729