Healthcare Industry News: Bard
News Release - April 16, 2007
E-Z-EM Receives FDA 510(k) Clearance for EmpowerMR Injector SystemLAKE SUCCESS, N.Y.--(HSMN NewsFeed)--E-Z-EM, Inc. (NASDAQ:EZEM ) today announced that the Company has received 510(k) clearance from the Food and Drug Administration (FDA) for its EmpowerMR(TM) injector system--the Company's first product for the magnetic resonance (MR) imaging market. Building on the Company's successful Empower family of CT injector systems, EmpowerMR has the same easy-to-use interface and robust safety features as the other products in the Empower injector line. EmpowerMR also employs several innovative features designed to cope with the problem of electrical interference in the magnetic field of the MR scanner.
Magnetic resonance imaging systems operate by detecting minute variances in the alignment of molecules within certain tissues of the human body. To detect these variances, MR systems create powerful magnetic fields, and require the use of non-magnetic materials and components in the immediate surroundings of the scanner. Electromechanical devices like injector systems can create both electric and magnetic fields that cause electrical interference with the scanner during the imaging process, leading to image distortion or artifacts.
To minimize this problem, EmpowerMR employs a unique, patent-pending hydraulic control system instead of the shielded electrical control components used by most other MR injectors systems. EmpowerMR has no shielded iron core motors, piezoelectric motors or electrically active motor control circuitry adjacent to the scanner, which significantly minimizes the prospect of electrical interference with the scanner's magnetic field. EmpowerMR provides for utilization in MR field strengths up to 7 Tesla. EmpowerMR is also not battery operated, and links to its electrical supply by a single pass-through cable that does not require special shielding. As there is no motor in the MR suite, EmpowerMR does not generate audible noise. EmpowerMR's hydraulic control also means the system can deliver consistent flow rates, volumetric and pressure performance on demand--features which may help improve productivity in the MR suite.
According to recent data from IMV Limited, a medical technology market analysis firm, there are approximately 6,000 MR scanners in the United States and approximately 15,000 worldwide. Currently, approximately 20% of MR procedures involve the use of injected contrast.
Commenting on the announcement, Anthony A. LomBardo, President and Chief Executive Officer, "EmpowerMR is a natural addition to our family of injector products, and offers the same feature set and interface that made our Empower line an award winner. With its unique hydraulic control systems, we believe it is one of the most innovative injector systems available to the imaging market, and when coupled with our IRiSMR(TM) data management software, EmpowerMR will provide superior injection data management capability as well. We look forward to formally launching EmpowerMR in the coming weeks and for the product to be a contributor to sales in our next fiscal year."
About E-Z-EM, Inc.
E-Z-EM is a leading manufacturer of contrast agents for gastrointestinal radiology. The Company is the developer of VoLumenŽ--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 EmpowerŽ-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; successful launch, market acceptance and future sales of Empower MR injector systems, market acceptance and sales of VoLumenŽ; 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 March 3, 2007. 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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