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501(k) FDA Clearance for Electrodiagnostic System

March 21, 2012

CareFusion's Viking on Nicolet EDX system aids in enhanced electrophysiological testing and monitoring in hospitals and clinics.

SAN DIEGO, CA -- /PRNewswire/ -- CareFusion announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new electrodiagnostic system, known as the Viking on Nicolet EDX. The EDX system is a multi-modality device for monitoring and testing electrophysiological information from the human nervous and muscular system.

The new EDX system offers an intuitive, ergonomic platform and clinical automation that enables efficient, high-quality nerve conduction studies (NCS), electromyography (EMG) and evoked potential (EP) testing and intra-operative monitoring (IOM). The strong signal quality, environmental noise suppression capability and artifact rejection feature help reduce examination time, which can enhance patient comfort.

Designed with input from neurologists and electrodiagnostic technicians, the EDX system also helps improve workflow in busy clinical settings by effectively organizing data into a variety of reporting formats. With the versatile system, clinicians can complete their studies and generate reports with ease, helping to streamline workflow, improve clinician efficiency and lower costs.

"We are excited to bring the Viking on Nicolet EDX system to the U.S. market," said Mary de Sousa, vice president and general manager of the Nicolet business of CareFusion. "The EDX system helps strengthen our market-leading EMG portfolio and ensures clinicians and patients can benefit from the latest advancements in neurological care."

The EDX system will now be available in the United States and many other countries worldwide. The product will also be featured at the CareFusion booth at the American Academy of Neurology conference in New Orleans from April 23-26. Visit CareFusion at booth #801.

About CareFusion
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops market-leading technologies including Alaris infusion pumps, Pyxis automated dispensing and patient identification systems, AVEA, AirLife and LTV series ventilation and respiratory products, ChloraPrep skin prep products, MedMined services for data mining surveillance, Nicolet neurological monitoring and diagnostic products, V. Mueller surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs more than 14,000 people across its global operations.

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