Imaging3 Engages Intertek to Assist with Hazard Analytic Requirements Relating to the 510(k) Application with the FDA
Imaging3, Inc. [OTCQB:IGNG] announced today that on June 14, 2017 the Company hired Intertek, Inc. to remediate the hazard analytics and manage the FDA guidance protocols of submission requirements outlined by the FDA, in order to obtain approval for its Dominion VI imaging device with patented SmartScan™ 3D technology.
Intertek has an established track record of over 130 years in business and is an industry leader with more than 42,000 employees in 1,000 locations in over 100 countries. They deliver Quality Assurance expertise with industry-winning processes and a customer-centric culture. They ensure that products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world, and they hold extensive global accreditations, recognitions, and agreements.
President Dane Medley stated: “We continue to have extraordinarily high standards in our selection of vendors. The engagement of Intertek is yet another example, along with Med-Device Consulting, who is assisting with our 510(k) applications generally, and CriTech Research, who is assisting with the immense software component of our Dominion VI imaging device. This game-plan of working only with the best maximizes our chances of a successful outcome with the FDA.”
Special consultant Scott Pancoast added, “It is heartening to witness the transformation of Imaging3. The team has been successful in stabilizing its financials and now it is making great progress in stabilizing its operations. Choosing the right vendors is key, especially when working with complex regulatory matters.”
About Intertek, Inc. The mission of Intertek, Inc. is to assist companies in meeting their strategic objectives by providing highly specialized expertise and assistance with a project, either on a temporary or on-going basis. Find out more by visiting: http://www.m-dci.us THIS IS MED DEVICE’s WEBSITE! 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