EDDA Receives FDA Clearance For Its IQQA(R)-Chest Software For Digital X-Ray

PRINCETON JUNCTION, N.J., Nov. 22 /PRNewswire/ -- Imaging software company EDDA Technology announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its debut product, IQQA(R)-Chest software, an image analysis system that is specifically tailored for the softcopy review of digital chest radiographic images.

The IQQA(R)-Chest software carries the CE mark, and was also cleared by the Chinese State Food and Drug Administration for marketing and production in October 2004.

IQQA(R)-Chest is the first real-time interactive diagnostic analysis system, offering comprehensive tools not only for the identification but also for the quantification of nodules detected with projection chest radiography, the most commonly performed imaging procedure. In identifying nodules, physicians are able to use lesion-specific image enhancement viewing (LSEV) modes that dynamically detail image structures and highlight suspicious areas suggesting nodular abnormalities. Once suspect nodules are identified, the software offers regional analysis tools for the quantification of lesion characteristics including size, density and shape.

Combining lesion-specific image enhancement viewing and ROI (region of interest) evaluation tools, the software is designed to help radiologists with the identification, confirmation and quantification of pulmonary lesions. The software offers DICOM connectivity and automatically assembles diagnostic information into a clinical report for referring physicians and follow-up review. The “plug-and-play” software runs on standard PC platform.

“EDDA’s vision is to seamlessly integrate advanced diagnostic analysis technology into physicians’ softcopy reading process for improved workflow and clinical decision making,” said Jian-Zhong Qian, Ph.D., president and CEO of EDDA Technology. “Bridging the detection of pulmonary nodules with accurate characterization, IQQA(R)-Chest bolsters the image quality and workflow efficiency advantages of thoracic digital X-Ray. This combination will have a broad impact on improving nodule case diagnosis and patient prognosis, especially as digital X-Ray continues to gain market acceptance and acceleration.”

Lung cancer is the leading cause of cancer death among both men and women in the United States and worldwide. According to the American Cancer Society (ACS), there will be an estimated 160,440 deaths from lung cancer in the US in 2004. More people die of lung cancer than of colon, breast, and prostate cancers combined. When lung cancer is found and treated in the earliest stages, the average five-year survival rate is nearly 50 percent. However, only 16 percent of lung cancer cases are diagnosed at this early, localized stage.

A clinical study presented last month at the 11th International Conference on Screening for Lung Cancer in Rome, Italy, demonstrated that the IQQA(R)-Chest software helps to reduce inter-observer variation and to improve the detection rate of actionable nodules, especially small nodules (5-15mm) that are more likely to be overlooked. Conducted by Dr. Wei Song and Dr. Zhenyu Jin at the Peking Union Medical College Hospital in Beijing, China, the study involved the review of 232 chest DR cases from screening patients by physicians of different experience levels.

About EDDA Technology

EDDA Technology, Inc. is a 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. A privately held Delaware corporation, EDDA is headquartered in Princeton Junction, New Jersey, and has a regional office in Shanghai, China. For more information, please contact info@eddatech.com or call 609-936-8282.

Editor’s Note: EDDA Technology will be exhibiting the IQQA(R)-Chest software in the Mobile Computing Pavilion booth #1440 (Insight Sciences.com) at the 90th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Nov. 28 - Dec. 2, 2004.

EDDA Technology, Inc.

CONTACT: Xiaolan Zeng, Ph.D. of EDDA Technology, Inc., +1-609-936-8282,or xzeng@eddatech.com