Healthcare Industry News: virtual colonoscopy
News Release - November 27, 2006
E-Z-EM Receives FDA Approval for CAN-CiA Injector Sychronization DeviceLAKE SUCCESS, N.Y.--(HSMN NewsFeed)--E-Z-EM, Inc. (NASDAQ:EZEM ) today announced that the Company has received clearance from the Food and Drug Administration for its EmpowerSync(TM) system--a product based on the CAN-CiA (Controller Area Network-CAN in Automation) DSP 425 protocol. EmpowerSync permits synchronized operation of EmpowerCT® and EmpowerCTA® injector systems and CT scanners from all of the manufacturers who also adopt the DSP 425 standard. E-Z-EM is exhibiting EmpowerSync at the Radiological Society of North America (RSNA) meeting in Chicago from November 26 to December 1.
The CAN-CiA DSP 425 protocol is an internationally recognized standard for data transmission between scanners and contrast injector systems. The protocol permits automated and coordinated operation of both the scanner and the injector system from the scanner's control system, simplifying operation and reducing the burden on the radiologic technologist.
Commenting on the announcement, Brad S. Schreck, Senior Vice President-Global Sales, Marketing, and Engineering, for E-Z-EM, said, "The DSP 425 protocol is the coming standard for data transmission between injector systems and CT scanners. With receipt of FDA clearance for EmpowerSync, our EmpowerCT® and EmpowerCTA® injector systems will now be compatible with this standard. We believe EmpowerSync will help add ease of operation to the CT scanning process, and help further the leadership position of our Empower line of injectors."
About E-Z-EM, Inc.
E-Z-EM is a leading manufacturer of contrast agents for gastrointestinal radiology. The Company recently introduced VoLumen® the next generation low density barium sulfate suspension for use as an oral contrast in Multidetector CT (MDCT) and Positron Emission Tomography (PET/CT) studies. The Company also offers Empower®-the only family of CT injectors on the market with patented EDA(TM) technology that can help detect contrast extravasation-and offers a complete product set for the virtual colonoscopy practitioner. This product line consists of virtual colonoscopy hardware, software, nutritional prep kits and bowel cleaners, tagging agents and a carbon dioxide colon insufflation system. The Company is also the exclusive world-wide manufacturer and marketer of RSDL for first-responder organizations and military services. RSDL is a patented, broad spectrum liquid decontaminant, that neutralizes and/or removes chemical warfare agents and T-2 toxins from skin.
The statements made in this document contain certain forward-looking statements. Words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates" or variations of such words and similar expressions, are intended to identify such forward-looking statements. The forward-looking statements contained in this release may involve numerous risks and uncertainties, known and unknown, beyond the Company's control. Such risks and uncertainties include: the ability of the Company to develop its products; the impact and future sales of Empower injector systems derived from FDA clearance of EmpowerSync(TM), market acceptance and sales of VoLumen®; future actions by the FDA or other regulatory agencies, overall economic conditions, general market conditions, price increases of raw materials and components, foreign currency exchange rate fluctuations as well as the risk factors listed from time to time in the SEC filings of E-Z-EM, Inc., including but not limited to its Annual Report on Form 10-K for the fiscal year ended June 3, 2006 and its 10-Q for the quarter ended September 2, 2006. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements, and investors are cautioned not to place undue reliance on the forward-looking statements included in this release.
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