Imaging3 Engages Med-Device Consulting, Inc. to Assist on 510(k) Application with the FDA
Burbank, CA, June 12, 2017 (GlobeNewswire): Imaging3, Inc. [OTCQB:IGNG] announced today that on June 5, 2017 the Company hired Med-Device Consulting, Inc. to facilitate the 510(k) application to the FDA in order to obtain approval for its Dominion VI imaging device with patented SmartScan™ 3D technology.
Med-Device Consulting provides a wide range of personalized regulatory and medical quality-assurance consulting services. They have helped numerous medical device companies worldwide with 510(k) submissions, with quality-assurance and regulatory systems, with CE-mark preparation, and with ISO certification. Med-Device represents client organizations throughout the nuanced process of engaging with the FDA, coordinates with the FDA on behalf of sponsors at meetings and via regular correspondence with the FDA during the entire lifecycle of a product, and provides support in all aspects of marketing applications, including review and editing, safety descriptions, and statistical analysis plans. They are replacing Biologics as the company’s primary regulatory liaison.
President Dane Medley stated: “As part of our regulatory success strategy, we have been extremely discriminating in our selection of vendors. The engagement of Med-Device Consulting is one such example; and the hiring of CriTech Research to validate the massive software component of our Dominion VI imaging device was another. With professionals like that providing guidance each step of the way, we are optimistic we will have a successful interaction with the FDA.”
Special consultant Scott Pancoast added, “Imaging3 continues to make progress, both financially and operationally. The addition of Med-Device to the team positions the company well for eventual FDA approval and commercial success.”
About Med-Device Consulting, Inc. The mission of Med-Device Consulting, Inc. is to assist companies in meeting their strategic objectives by providing highly specialized expertise and assistance on a project, temporary or on-going basis. Find out more by visiting: http://www.m-dci.us
About Imaging3 Inc. Imaging3, Inc., founded in 1993, has developed a patented medical imaging technology, called SmartScan™, that will produce 3D x-ray images, virtually in real time. The SmartScan technology will allow healthcare professionals to perform diagnostic and therapeutic procedures more quickly and accurately, resulting in higher throughput for the clinicians and fewer safety risks for the patient. In addition, Imaging3’s technology exposes patients to significantly less harmful radiation than current imaging technologies such as CT scans, which the company believes will allow scans to be used in more pediatric applications than are currently prescribed. The technology also allows for greater portability, easier installation, and a significantly reduced cost burden for the healthcare system overall. Imaging3 is planning to submit a 510K application to the FDA during 2017 in order to gain approval to commercialize the SmartScan technology.
Visit the company’s website at http://www.imaging3.com for detailed information about the Company’s technology.
Safe Harbor Statement
Imaging3 cautions you that any statement included in this press release that is not a description of historical facts is a forward-looking statement. Many of these forward-looking statements contain the words "anticipate," "believe," "estimate," "may" "intend," "expect" and similar expressions. 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 inherent in the Imaging3’s business, including, without limitation: the company may not ever obtain FDA approval for any of its devices; the company may not be able to secure the funds necessary to support its product development plans; and the company may not ever achieve the market success to sustain a profitable business. In addition, there are risks and uncertainties related to economic recession or terrorist actions, competition from much larger imaging companies, technological obsolescence, unexpected costs and delays, potential product liability claims, and many other factors. More detailed information about Imaging3 and the risk factors that may affect the realization of forward-looking statements is set forth in the company’s filings with the Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and its Quarterly Report on Form 10-Q. Such documents may be read free of charge on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Imaging3 undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Investor Relations Contact: Dane Medley President firstname.lastname@example.org