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EDDA Receives FDA Clearance for its IQQA®-Liver Software for Multiphase MDCT
Princeton Junction, NJ, November 16, 2006
EDDA Technology today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its IQQA®-Liver software, an image analysis system that provides diagnostic decision support for physicians' evaluation of hepatic lesions using multiphase Multi-Detector CT (MDCT).
IQQA®-Liver is the first diagnostic analysis system that provides real-time decision support for managing four dimensional patient liver image data (3 spatial dimensions, plus time). With the recent advances in MDCT and dynamic imaging, early detection and treatment planning of liver diseases has been significantly enhanced.However, with these advances comes the challenge of efficiently dealing with a tremendous increase in image data. With a typical multiphase liver study generating several hundred CT images, there has never been a more urgent need for radiologists to have access to tools that can support them in making more efficient and effective diagnoses.
Combining advanced image analysis algorithms and powerful visualization tools, IQQA®-Liver supports clinical workflow for physicians to quickly and effectively distill critical diagnostic information from image data sets of extraordinary size. The software performs automatic, anatomic phase registration to allow simultaneous visualization and easy cross-referencing of lesion location and features across the different phases.
IQQA®-Liver further provides segmentation and measurement tools for the visualization and analysis of liver lesions, hepatic vascular structures, as well as liver lobes. This volumetric analysis not only provides physicians with a powerful visualization aid, but also offers quantification tools to support their clinical decision making and patient care management.
"EDDA is committed to innovation, and to improving early detection, early diagnosis and precise treatment of lethal diseases through development of the most advanced computer technologies", says Dr. Jian-Zhong Qian, President and CEO of EDDA Technology. "Following EDDA's debut product IQQA®-Chest software for early lung lesion detection, IQQA®-Liver is another important step forward in this direction. We will continue our efforts to provide our customers with the new generation of diagnostic decision supporting solutions".
Liver disease is among the 10 major causes of death in the US, according to the American Liver Foundation.There are 25,000,000 Americans afflicted by liver disease. Primary liver cancer, an extreme type of malignancy that starts in the liver, is one of the most common malignancies in the world, with approximately 1,000,000 cases reported every year. This ranges from 16,000 new cases in the US to 500,000 in China. Liver metastasis tumors also occur frequently, as any primary cancer location can deposit metastases in the liver. As the liver is generally the first site of metastatic spread, aggressive surgical intervention at an early stage of metastasis results in a reported 25-40% five-year survival rate.
The IQQA®-Liver software has also been approved by the Chinese State Food and Drug Administration for marketing and production. It has been in clinical use in several luminary Chinese hospitals for liver cancer detection, diagnosis and treatment planning purposes, including Eastern Hepatobiliary Surgery Hospital in Shanghai, and Peking Union Medical College Hospital in Beijing.
EDDA Technology will feature IQQA®-Liver at the upcoming 92nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA). RSNA 2006 will also provide the occasion for EDDA to showcase IQQA®-Chest Enterprise: IQQA®-Chest supports physicians in the identification, evaluation and documentation of lung lesions from digital chest radiographic images. The new Enterprise version addresses the accessibility challenge for advanced clinical applications and provides a unique enabling solution capable of instantly deploying the full functionality of the IQQA®-Chest application on existing PACS review consoles without additional requirement or setup effort on the PACS workstations. IQQA®-Chest carries the CE mark, and has clearance from the U.S. FDA, and Chinese SFDA.
About EDDA Technology
EDDA Technology, Inc. is an innovative clinical computer solution provider in diagnostic imaging and analysis. EDDA offers a series of new generation software products to enable early detection of diseases and enhance precision in diagnosis. EDDA's goal is to deliver advanced information analysis technologies that improve clinical workflow and accuracy with broad accessibility. A privately held Delaware corporation, EDDA is headquartered in Princeton Junction, New Jersey, and has a regional office in Shanghai, China. In April 2006, EDDA entered into a strategic partnership with Philips Medical Systems to provide advanced digital radiography solutions to assist in the detection of lung lesions. IQQA is a registered trademark of EDDA Technology. For further information, please log on to www.edda-tech.com, or contact firstname.lastname@example.org or call 609-936-8282.
EDDA Technology exhibit their IQQA® Family of Products in Booth # 3271 in the South Hall of McCormick Place at the 92nd Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Nov. 26 – Dec. 1, 2006.