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R2 Technology, Inc. Announces FDA Approval Of An Integrated Digital CAD System For Use With Siemens' MAMMOMAT NovationDR Full-Field Digital Mammography System

Published: Feb 22, 2005

SUNNYVALE, Calif., Feb. 22 /PRNewswire/ -- R2 Technology, Inc. today announced that the company has received FDA approval to expand the use of its ImageChecker(R) D product for CAD processing of images acquired with the Siemens Medical Solutions MAMMOMAT(R) NovationDR and viewed on Siemens' MammoReportPlus softcopy reporting workstation.

Under the terms of an agreement signed in 2002 and renewed in 2005, Siemens and R2 have exclusive worldwide distribution rights to sell the R2 customized product in combination with Siemens MAMMOMAT NovationDR. Worldwide shipments of the integrated system are expected to begin shortly.

"Siemens Medical teamed up with R2 Technology in 2002 to customize and develop innovative technology to promote women's healthcare and the early detection of breast cancer worldwide. By combining our excellent products, we have created innovative solutions that improve our customer's workflow and their quality outcome," said Holger Schmidt, head of the Special Systems Division at Siemens Medical Solutions.

Computer-aided detection is used by an increasing number of radiologists as "a second pair of eyes" when reading mammograms. Clinical trials demonstrated that use of the R2 ImageChecker system could result in earlier detection of up to 23.4 percent of the cancers currently detected with screening mammography in those women who had a prior screening mammogram 9-24 months earlier.

The ImageChecker system from R2 Technology was the first CAD system approved by the FDA for use with mammography. Since 1998, R2 Technology has received 17 supplemental approvals for technological and clinical advances. To date, more than 1,500 ImageChecker CAD systems have been shipped worldwide. This year over eight million women will have their mammograms interpreted with the aid of this leading CAD technology for the early detection of breast cancer.

"R2 Technology and Siemens share a common goal to provide compelling and clinically relevant solutions that improve women's health. In this case, it is providing proven CAD technology for use with digital mammography that improves the early detection of cancer," said John Pavlidis, president and CEO of R2 Technology, Inc. "The combination of Siemens' FFDM systems with our customized CAD technology offers excellent new capabilities in the fight against breast cancer."

MAMMOMAT NovationDR features an innovative flat panel detector based on amorphous Selenium (aSe) detector technology. This technology enables a direct conversion of X-ray to digital information, unlike some other detector systems, such as amorphous silicon (aSi-CsI), which use indirect x-ray conversion. The aSe detector technology has the potential to provide higher spatial resolution and greater clinical detail. At 24 by 29 centimeters, the image detector of MAMMOMAT NovationDR also enables imaging of a larger range of patient sizes, and the system features a paddle designed for easier and more comfortable patient positioning.

About Siemens Medical Solutions

Siemens Medical Solutions of Siemens AG 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 31,000 people worldwide and operating in more than 120 countries, Siemens Medical Solutions reported sales of 7.07 billion EUR, orders of 8.12 billion EUR and group profit of 1.05 billion EUR for fiscal 2004.

More information can be obtained by visiting http://www.usa.siemens.com/medical-pressroom .

About R2 Technology, Inc.

R2 Technology, Inc., headquartered in Sunnyvale, Calif., is a recognized leader in the development and commercialization of computer-aided detection (CAD), an innovative technology that assists radiologists in the early detection of breast cancer, actionable lung nodules and other lung abnormalities. As a medical software company, R2 Technology is developing CAD systems for a variety of imaging modalities and disease states. R2 was given the 2004 Frost and Sullivan Product of the Year award for its' innovative product for lung nodule detection for chest Multi-Detector CT.

For information, visit http://www.r2tech.com/.

NOTE: ImageChecker is a registered trademark of R2 Technology, Inc.

R2 Technology, Inc.

CONTACT: media, Betsy Davis of R2 Technology, Inc., +1-408-481-5633, orbdavis@r2tech.com

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