BURBANK, CA--(Marketwire - September 08, 2011) -
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 announced that the company has submitted their Imaging Protocol Proposal to the FDA for review and to schedule a face-to-face meeting with the FDA and Imaging3's Submission Team.
"I am pleased to announce that Imaging3 has completed the first of three phases in our FDA 510(k) resubmission strategy with the delivery of our Imaging Protocol Proposal to the FDA today. I'm personally very proud of our consulting team at achieving this important milestone. It has taken a great deal of time and effort to complete this most crucial phase," commented Mr. Dean Janes, CEO and Chairman of Imaging3.
"Management feels confident with the assistance of our consulting team and our new three phase strategy, though not guaranteed, FDA 510(k) approval is achievable. We look forward to our meeting with the FDA to discuss our submission and receive guidance directly from the FDA," Mr. Janes concluded.
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 http://www.imaging3.com for more information
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, technological obsolescence, competition from other medical instrument(s) and imaging companies, lack of capital, unexpected costs, failure or delay of FDA approval, absence of revenue, the impact on the national and local economies resulting from an economic recession or terrorist actions, and U.S. actions subsequently; unavailability of financing for the Company or its customers, product malfunction and potential product liability claims, and other factors detailed in reports filed by the Company.