Siemens Receives FDA Approvable Letter for Its Digital Mammography Solution

(July 01, 2004)

Siemens Medical Solutions has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the MAMMOMAT® NovationDR*, a full-field digital mammography system. This letter indicates that the FDA has completed its scientific review of the company's Pre-Market Approval (PMA) application.


In the approvable letter for this device, the FDA indicates that the MAMMOMAT NovationDR is approvable for release to the market, pending the successful completion of an FDA inspection of Siemens' manufacturing facility in Erlangen, Germany, and completion of the device labeling for the system.

"We are pleased that the FDA has taken the next step in approving our application to market this state-of-the-art, digital women's health product in the United States," said Holger Schmidt, president of the Siemens Medical Solutions Special Systems Division. "Once approved, the MAMMOMAT NovationDR will offer our customers a comprehensive digital solution for modern mammography."

The new MAMMOMAT NovationDR provides digital screening, diagnosis, and stereotactic biopsy capabilities - all in one system. It features an innovative flat panel detector based on amorphous Selenium (aSe) technology, enabling a direct conversion of X-ray to digital information. The aSe detector technology has the potential to provide higher spatial resolution and greater clinical detail.

At 25 by 29 centimeters, the size of the MAMMOMAT NovationDR image detector enables imaging of a wider range of patient breast sizes. The system also features an acquisition workstation and the MammoReportPlus, a dedicated softcopy reporting workstation that allows ultra-fast loading times. In fact, one case with eight images can load in less than one second.

Siemens Medical Solutions of Siemens AG (NYSE: SI - News) with headquarters in Malvern, Pa., 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 7.4 billion EUR, orders of 7.8 billion EUR and group profit of 1.1 billion EUR for fiscal 2003. More information can be obtained by visiting http://www.usa.siemens.com/medical.

CAUTION - Investigational Device. Limited by U.S. Federal law to investigational use. These devices are not yet commercially available in the U.S.