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Siemens New Computer-Aided Detection Program Helps Physicians Detect More Lung Nodules.

syngo([R]) Lung CAD Receives Pre-Market Approval (PMA) from the FDA

MALVERN, Pa. -- Digital diagnostic images and electronic patient data are becoming ever more comprehensive and detailed. For this reason, the use of Computer-Aided Detection (CAD) tools is on the increase to help physicians in the interpretation of diagnostic information. Siemens Medical Solutions (www.usa.siemens.com/medical) has received the approval letter from the U.S. Food and Drug Administration (FDA) for its syngo([R]) Lung CAD device, which is designed to assist radiologists in the detection of solid lung nodules in computed tomography (CT) examinations of the chest.

"We are excited that the FDA has approved the application to market our CAD product for thoracic CT examinations," says Alok Gupta, Ph.D., M.B.A., vice president of Computer-Aided Diagnosis and Knowledge Solutions, Image and Knowledge Management Division, Siemens Medical Solutions. "The results of our clinical study provide compelling evidence of Siemens' continuous focus and commitment to improving clinical outcomes. syngo Lung CAD is an integral part of our strategy to develop innovative CAD products for multiple modalities and applications."

syngo Lung CAD was validated on the use of CAD in thoracic CT examinations in the largest multi-center, multi-reader study performed to date. Each of the nearly 200 cases was reviewed by 17 radiologists using data from four leading medical centers in the U.S. The use of syngo Lung CAD as a second reader helped all participating radiologists to significantly increase their detection accuracy for clinically significant lung nodules.

"The results represent important confirmatory evidence for the use of CAD in thoracic CT examinations," said David Naidich, M.D., professor of Radiology and Medicine at NYU Medical Center, and principal investigator of the study.

"syngo Lung CAD adds significant new capabilities to the syngo LungCARE CT application by increasing the medical professional's ability to catch more pulmonary nodules during the review of CT studies with hundreds of images," said Louise McKenna Ph.D., M.B.A., global clinical marketing manager, Onco CT, CT Division, Siemens Medical Solutions.

It is based on proprietary image processing and pattern recognition algorithms that have been extensively trained on a large database of thoracic CT studies. syngo Lung CAD is designed to detect a range of nodule sizes, starting at three millimeters in diameter. The automatically detected nodules cover the full range of locations and contours and the CAD software works equally well in the presence or absence of intravenous contrast.

In combination with the underlying software syngo LungCARE CT growth rate and nodule size of detected nodules can easily be compared by automated alignment and volume calculation, thus supporting the physician's treatment regimen.

syngo Lung CAD represents the second generation nodule detection software from Siemens following syngo LungCARE NEV (Nodule Enhanced Viewing), which was introduced in December 2003 and has already reached more than 500 installations worldwide. syngo Lung CAD seamless integration into the syngo LungCARE CT application, allows Siemens to provide a comprehensive solution for the detection, evaluation and follow-up of lung nodules. syngo Lung CAD will be available on the syngo MultiModality Workplace.

Siemens Medical Solutions of Siemens AG (NYSE:SI) with headquarters in Malvern, Pennsylvania, and Erlangen, Germany, is one of the largest suppliers to the healthcare industry in the world. The company is known for bringing together innovative medical technologies, healthcare information systems, management consulting, and support services, to help customers achieve tangible, sustainable, clinical and financial outcomes. Employing approximately 33,000 people worldwide and operating in more than 120 countries, Siemens Medical Solutions reported sales of 7.6 billion EUR, orders of 8.6 billion EUR and group profit of 976 million EUR for fiscal 2005. More information can be obtained by visiting www.usa.siemens.com/medical-pressroom.
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Publication:Business Wire
Date:Oct 20, 2006
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