GE Medical Systems Receives FDA Clearance for Innova 4100; Real-Time Digital Imaging To Advance Interventional Care By Providing Clearer, Larger Images With Less Dose.Business Editors/Health & Medical Writers/Photo Editors WAUKESHA, Wis.--(BUSINESS WIRE)--Nov. 26, 2002 GE Medical Systems, a unit of General Electric Company (NYSE NYSE See: New York Stock Exchange : GE), today announced that it has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for the GE Innova(TM) 4100. This large-format digital flat panel Digital Flat Panel (DFP) is a video connector for flat panel displays. It features 20 pins and uses the PanelLink protocol. Unlike DVI, DFP never achieved widespread implementation. The connector was used by displays such as the Compaq Presario FP400, FP500 and 5204. X-ray system, the first of its kind, provides detailed, real-time fluoroscopic Fluoroscopic (fluoroscopy) An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations. Mentioned in: Hypotonic Duodenography images of human anatomy for interventional radiological procedures that require exacting precision. The GE Innova 4100 is expected to help physicians treat a variety of medical disorders including peripheral vascular, cardiovascular and neurological diseases, uterine fibroids Uterine Fibroids Definition Uterine fibroids (also called leiomyomas or myomas) are benign growths of the muscle inside the uterus. They are not cancerous, nor are they related to cancer. , and other conditions, without major surgery. With the Innova 4100, physicians will be able to see clearly inside a patient with digital real-time imaging 'real-time' imaging Visualization of a dynamic process µsecs after occurring, which requires rapid information processing–ie, as the process occurs, as in 'B' mode ultrasound while guiding catheters and other medical devices to areas of the body needing treatment. The Society of Interventional Radiology cites several benefits of interventional radiology procedures compared to traditional surgeries including: reduced risk, less pain, shorter patient recovery times and lower procedure expense. The number of procedures being performed by Interventional Radiologists in the U.S. is growing by 5 percent per year and expected to reach over 4 million by 2003. According to Hal Folander, MD, Chief of Radiology at St. Luke's Hospital & Health Network in Bethlehem, Pennsylvania, the GE Innova 4100 opens a new era for a wide range of interventional care by producing clearer fluoroscopic images with a larger field of view. "This new technology will help physicians around the world further advance the effectiveness of interventional procedures," said Dr. Folander, who led the study of the Innova 4100 during clinical trials of the system. "Images created by the GE Innova 4100 provide us with the most detailed and efficient information we have ever had." Specifically, the Innova 4100 can provide physicians with exceptional image clarity with 10 times the dynamic range and a 37 percent larger field of view. Because physicians can image more anatomy in a single series with the Innova 4100, a complete study can be done with fewer X-ray images, less X-ray dose and fewer injections of contrast dye when compared to current systems. The Innova 4100 system features GE's unique Revolution(TM) digital flat panel detector technology. By converting X-ray signals into digital images at the point of acquisition, the Revolution detector captures information over the full range of typical exposures, enables exceptional image clarity with a large field of view, and eliminates the artifacts artifacts see specimen artifacts. and distortions of conventional image-intensifier chains. The GE Innova 4100 is designed for efficient imaging procedures and patient comfort with the industry's only 3-axis gantry Gantry A name for the couch or table used in a CT scan. The patient lies on the gantry while it slides into the x-ray scanner portion. Mentioned in: Computed Tomography Scans positioning for greater flexibility for a wide variety of clinical applications. "Based on the positive feedback we have received from physicians, we expect the Innova 4100 to be used in more than 100 leading medical institutions by 2003," said Dow Wilson, General Manager of Global Surgery, X-ray, and Interventional Imaging for GE Medical Systems. The GE Innova 4100 was designed using Six Sigma quality principles, which incorporated input from hundreds of physicians worldwide. About GE Medical Systems GE Medical Systems is a $9 billion global leader in medical imaging, interventional procedures, healthcare services, and information technology. Its offerings include networking and productivity tools, clinical information systems, patient monitoring systems, surgery and vascular imaging, conventional and digital X-ray, computed tomography, electron beam tomography Electron beam tomography is a specific form of computed axial tomography (CAT or CT) in which the X-Ray tube is not mechanically spun in order to rotate the source of X-Ray photons. , magnetic resonance, ultrasound and bone mineral densitometry densitometry /den·si·tom·e·try/ (den?si-tom´i-tre) determination of variations in density by comparison with that of another material or with a certain standard. , positron emission tomography positron emission tomography: see PET scan. positron emission tomography (PET) Imaging technique used in diagnosis and biomedical research. , nuclear medicine, and a comprehensive portfolio of clinical and business services. For more than 100 years, health care providers worldwide have relied on GE Medical Systems for high quality medical technology and productivity solutions. For more information, visit the GE Medical Systems Web site at www.gemedical.com |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion