Siemens Receives FDA 510(k) Clearance for the MVision Megavoltage Cone Beam Imaging Package

New Radiation Treatment Solution for Adaptive Radiation Therapy Enables Improved Treatment Accuracy

Concord, Calif., Apr 3, 2006, The U.S. Food and Drug Administration (FDA) has granted Siemens Medical Solutions 510(k) clearance for the MVisionTM Megavoltage Cone Beam (MVCB) Imaging Package. Commercially available worldwide, MVision is the latest innovation in Siemens’ portfolio of Adaptive Radiation Therapy (ART) solutions.

MVision is a unique volumetric in-line target imaging solution and the natural next step in Image-Guided Radiation Therapy (IGRT). Designed to work with Siemens’ linear accelerators, the system is the first commercial implementation of cone beam technology utilizing a standard radiotherapy treatment beam. MVision makes it possible for the megavoltage (MV) source used for treatment to also create a 3D image of the patient, enabling clinicians to “see inside” the patient at the most appropriate moment.

“Megavoltage cone beam imaging has demonstrated excellent and clinically useful soft tissue contrast needed for many disease sites,” states Ajit Singh, Ph.D., president, Oncology Care Systems, Siemens Medical Solutions. “With MVision, this is achieved without sacrificing dose or time efficiency.”

Designed to complement a clinic’s oncology workflow, MVision fully integrates and automates all processes, including acquisition, reconstruction, registration, assessment, patient positioning and clinical review. With a few simple steps, therapists can calculate 3D offsets, send them to the treatment couch to compensate for daily variations, and safely deliver therapy.

MVision does not require an independent imaging source for IGRT, thus maximizing clinical accessibility and patient comfort. This innovation also frees caregivers from performing unnecessary electromechanical maintenance, so they can focus on versatile and efficient patient care.

About Siemens Medical Solutions

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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