Imaging3, Inc. FDA 510(k) Protocol Meeting Update
BURBANK, CA--(Marketwire - November 01, 2011) -
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Dean Janes, Chairman and CEO of Imaging 3, commented, "I am able to report to you that our October 17, 2011 meeting with the FDA went as anticipated and we have successfully completed the second milestone of our three phase submission process. The meeting's primary objective was to submit our imaging protocols for acquiring and reviewing images. This objective was achieved and, overall, the meeting was productive for the Company in several other areas, some of which I will outline here and in future updates as information continues to become available."
"Of primary importance, our team confirmed with the FDA that our submission will be a 510(k) as we had predicted. The 510(k) approval process is the most advantageous submission for Imaging3 to pursue, since it provides the shortest route to a potential approval and includes neither complicated nor time consuming clinical trials. The Agency has asked us to provide live patient data, which was a possibility we anticipated and under the 510(k) process this requirement is manageable."
"Another important element of the meeting was the opportunity to ask questions and receive guidance regarding the submission. As a result we have gained a great deal of insight as to what is needed to complete our submission, in addition to creating an open line of communication with the FDA. Our questions regarding our past submission(s) received direct answers, providing us helpful information towards creating a successful submission in the future," stated Dean Janes.
"In summary, the feedback we received in this meeting has energized our team and, based on the FDA's input, we immediately began implementing their suggestions. As always we appreciate your continued support and we will update you as permitted while we progress through this final phase," Mr. Janes concluded.
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 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.
Contact:
Imaging3, Inc.
800-900-9729