BURBANK, Calif., Feb. 21, 2017 (GLOBE NEWSWIRE) -- Imaging3, Inc. (OTCQB:IGNG) announced today that, after several months of verification and validation, CriTech Research Inc. has completed its remediation review and testing of Imaging3 DominionVI SmartScan™ software, thus allowing the company to move forward towards filing its FDA 510(k) application.
For over 23 years, CriTech has developed and tested safety-critical software and systems for medical devices. Their customers range from large, established companies to startups, with products from all FDA device classes (I, II, III) and IEC 62304 software-safety classifications.
CriTech follows an IEEE-based critical software development process, which is a fundamental part of its quality system. This system is compliant with the FDA Quality System Regulation, which supports 510(k) and PMA submissions.
CriTech’s history of success is proven: Having completed over 400 remediation/testing protocols, all of them received first-time FDA and/or EU approval.
Dane Medley, president of Imaging3 stated: “It was fantastic working with CriTech and their team of engineers. CriTech has completed the software remediation/testing of our SmartScan™ software, and upon receipt of our final payment, CriTech will deliver the required documentation and final reports. The software is the lion’s share of the technology underpinning our DominionVI imaging device, so CriTech’s stamp of approval gives us confidence that we will find success with our 510(k) approval process.”
Scott Pancoast, special advisor, stated: “This is yet another significant milestone for Imaging3 and, given CriTech’s amazing success rate in the past, bodes well for things to come.”
About Imaging3
Imaging3, Inc., founded in 1993, has developed a patented medical imaging technology, called SmartScan™, that will produce 3D medical diagnostic images in real time. Imaging3’s SmartScan™ technology will allow healthcare professionals to perform diagnostic and therapeutic procedures more quickly and accurately, with fewer risks for the patient. Imaging3’s technology exposes patients to significantly less harmful radiation than current imaging technologies such as CT scans—this, 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 fact 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 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 companies, technological obsolescence, unexpected costs and delays, potential product liability claims, and many other factors. More detailed information about Imaging3 (and the specific 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.