Major manufacturer of contrast agents for gastrointestinal radiology selects clinivation WorldView as its most comprehensive, authoritative resource for building its medical product submissions and registrations worldwide.
Natick, MA, June 3, 2008 – clinivation, Inc. announced today that E-Z-EM, Inc. has selected clinivation WorldView® Online Regulatory Intelligence web service. Bracco Diagnostics, Inc., the U.S.-based subsidiary of Bracco Imaging SpA, and part of the Bracco Group, announced on April 1, 2008 the final acquisition of E-Z-EM, Inc.
“E-Z-EM, along with the Bracco Group, are clearly innovative, global leaders in diagnostic imaging,” said Richard Morroney, R.A.C., C.Q.A., clinivation’s Vice President of Quality and Regulatory Solutions. “With clear, step-by-step registration processes for >99% of the world markets, E-Z-EM will have access to important regulatory and compliance information in one centralized place,” he continued.
Clinivation WorldView is your most comprehensive, authoritative, and up-to-date resource for building all of your medical device submissions and registrations worldwide. Clinivation WorldView also interoperates with clinivation Global® enterprise software to make building and tracking medical device submissions and registrations easier than ever before.
About E-Z-EM, Inc.
Headquartered in Lake Success, New York, and named to Forbes magazine’s prestigious 2007 List of Best Small Companies in America, E-Z-EM is a recognized leader in manufacturing products for imaging the gastrointestinal (GI) tract. From the first disposable barium enema administration kit introduced in 1962, to today’s advanced CT and VC products, speech pathology, GI devices and healthcare decontaminants, E-Z-EM continues to develop imaging solutions that provide superior methodology, procedural simplicity and added convenience for physicians and their patients.
The company is the developer of VoLumen®, a patent-pending low density barium sulfate suspension for use as an oral contrast in Multidetector CT and Positron Emission Tomography (PET) studies. It also offers Empower®, the first family of CT injectors on the market with patented technology to help detect contrast extravasation and a complete product set for virtual colonoscopy practitioners, comprising virtual colonoscopy hardware, software, nutritional prep kits and bowel cleaners, tagging agents and a carbon dioxide colon insufflation system.
For more information, please visit www.ezem.com.
About Bracco Imaging
Bracco Imaging SpA is one of the world-leading companies in the imaging agent business, with products sold in over 80 countries and about 1,250 employees, around 300 of whom work in R&D, Medical and Regulatory Affairs.
Bracco Imaging is headquartered in Milan, Italy.
Bracco Imaging is a subsidiary of Bracco SpA, holding company of the Bracco Group, which also markets Ethical and OTC pharmaceutical products and Healthcare Services in Italy, as well as Advanced Medical Technology systems on a worldwide basis, through the Bracco AMT companies, ACIST Medical Systems and Volume Interactions of Singapore.
For more information, please visit www.bracco.com.
The Bracco Group is a worldwide integrated Healthcare Group with annual turnover of about 900 million Euro – around 60% of which is from foreign sales, and is one of the world-leading companies in the imaging agent business through Bracco Imaging SpA.
Bracco is present in approximately 80 countries both directly and through joint-ventures or affiliates, and currently employs more than 2,300 people worldwide over 300 of which are dedicated to R&D, Medical and Regulatory Affairs.