Imaging3 Signs Agreement to Work With Experien Group

Imaging3 Inc., a development stage company introducing disruptive technologies in the medical imaging industry, has signed an agreement with Experien Group, a Silicon Valley-based medical device consulting firm. Experien Group will provide regulatory strategy and execution in the company’s efforts to secure marketing authorization from the U.S. Food and Drug Administration (FDA) for the Dominion SmartScan. 
 
“Enlisting the assistance of Experien Group reflects our commitment to this critical step towards commercialization. Michael, Darlene and the rest of Experien Group’s team are seasoned veterans of medical device regulatory efforts,” said CEO John Hollister. 
 
Experien Group, founded by Michael J. Billig and Darlene Crockett-Billig, is a regulatory consultancy with offices in San Jose and San Diego, Calif. They provide a full range of regulatory, quality and clinical consulting services to medical device companies of all sizes. Experien Group’s senior team has more than 250 years of collective experience and will serve as a new extension of Imaging3’s organization, setting their regulatory strategy, compiling documentation, leading interactions with FDA and executing to major milestones, such as the filing and review of their 510(k) pre-market notification.  
 
“Experien Group remains deeply committed to helping commercialize paradigm-changing devices that improve patient care and people’s lives. After speaking with John, it became clear to our firm that Imaging3 has an incredibly innovative technology and a crucial renewed commitment to taking a prudent, thoughtful and transparent approach with FDA,” said Billig, CEO. 
 
Imaging3 Inc., founded in 1993, has developed a patented medical imaging technology, called the Dominion SmartScan, that produces 3D X-ray images, effectively in real time. The SmartScan technology has the potential to allow healthcare professionals to perform diagnostic and therapeutic procedures more quickly and accurately, which may result in higher throughput for the clinicians and fewer safety risks for patients. Imaging3’s technology exposes patients to less harmful radiation than current equivalent imaging technologies such as CT scans. The company believes this will allow scans to be used in many settings where scanning is currently limited by concerns about radiation exposure. The technology also notably allows for reasonably convenient portability, easier installation and use-readiness, and a significantly reduced cost burden suitable for novel settings and for healthcare systems across varied global settings. Imaging3 plans to submit a 510(k) application to FDA during 2018 to gain marketing authorization for initial applications for the SmartScan technology.