Burbank, CA – 2016 (Globe Newswire) Imaging3™, Inc. (the “Company”) (OTCQB: IGNG) announced today that on August 26, 2016 the Company signed a DVIS Software Remediation Proposal and accompanying with CriTech Research, Inc. of Saline, MI (“CriTech”), by which CriTech agrees to document, verify and validate the Company’s patented device software for presentation to the United States Food and Drug Administration (the “FDA”) as part of the Company’s planned submission of an application for a 510(k) approval for its Volumetric Imaging Scanner (the “VIS”). The project actually commenced on August 25, 2016.
CriTech, an acknowledged industry leader, develops and tests safety-critical software and systems for medical device applications. They have more than 20 years of experience creating custom solutions, tailored to meet its clients’ specific FDA software approval needs. Their comprehensive understanding of the software verification, validation and remediation requirements of the medical device industry has resulted in FDA approval and the grant of European Union CE Mark for hundreds of devices. CriTech’s customers range from large, established companies to startups, with products from all FDA device classes (I, II, III) and IEC 62304 software safety classifications (A, B, C). Their proven history of success with medical device software validation & verification and remediation extends to over 380 devices completed – all of them receiving first-time FDA and/or EU approval.
Dane Medley, Chairman/CEO of Imaging3 commented, “We are very pleased that CriTech has agreed to act as our software advocate in connection with the FDA 510(k) application and approval process for the “VIS”, even after our arduous reorganization process, of which they were aware every step of the way. CriTech’s no nonsense approach to software verification, validation, and remediation in the medical field fits well with our Company’s overall approach and their proven success rate lends undeniable credibility to our project. To have a truly best in class firm like CriTech as a working partner as we prepare to approach the FDA with our 510(k) application engenders confidence in the Company’s management and investors. This step helps us continue to build momentum toward our goal of FDA approval of our first imaging device utilizing our technology.”
CriTech’s President, Robert J. Rajewski, said: “CriTech is excited to work with Imaging3 in its endeavor to seek 510(k) approval from the FDA. Imaging3’s decision to select CriTech and its Independent Verification and Validation services indicates Imaging3’s desire to provide proven, best-in-class medical technology. We appreciate the trust Imaging3’s executive team has placed in us.”
About CriTech Research
CriTech is in the business of helping medical device companies save money and mitigate risk. They are experts in software testing for medical devices. They offer software V&V (verification and validation) and software remediation services to medical device companies. They have helped over 380 products receive first time FDA and/or EU approval.
CriTech has been in business for over 22 years. In that time, they have worked with start-up companies, and the largest corporations in the medical device industry – and many companies in between. CriTech is headquartered in Saline, MI, just south of Ann Arbor. CriTech’s web page address is www.critech.com.
The Company intends to provide ongoing updates of relevant material information to the public in the form of appropriate filings and press releases, all of which will be available on EDGAR, the OTCMarkets website and our Company website, www.imaging3.com.
Imaging3, Inc., founded in 1993, has developed a patented medical imaging technology that will produce 3D medical diagnostic images in real time in each of single 3D Safe-Scan, Continuous 3D Scan and CT Safe-Scan mode. The Company’s technology will allow healthcare professionals utilizing Imaging3 lightweight portable devices to view 3D, high resolution images of virtually any part of the human body in real time, even as they are performing procedures. The technology utilizes high resolution fluoroscopy to construct 3D images in real time. Such images are useful in helping health care professionals safely perform procedures on or in the human body. In addition, the Company’s technology exposes patients to significantly less harmful radiation than current imaging technologies such as CT scans. The Company believes this lower radiation exposure allows scans to be used in more pediatric applications than are currently prescribed. Perhaps most important, the Company believes that its technology will significantly reduce the cost of essential imaging to the healthcare system. The Company’s technology and imaging devices based upon it may not be used in human applications in the United States until the Company obtains FDA 510(k) approval of specific applications of its technology. However, the Company has not yet reapplied for FDA approval of any application of its technology (which FDA approval was denied in 2013) and there can be no assurance that the Company will obtain sufficient funding to reapply for any FDA approval or that, even if such funding is achieved, the Company will ever receive FDA approval of any possible application of its technology.
Visit the company’s website at http://www.imaging3.com for detailed information about the Company’s technology.
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, failure to consummate desired business combinations or transactions, 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, potential product liability claims, and other factors detailed in reports filed by the Company.
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