CareFusion Gets FDA OK for New Electrodiagnostic System

CareFusion 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.
 
According to the company, the new EDX system offers an intuitive, ergonomic platform and clinical automation that enables efficient, high-quality nerve conduction studies, electromyography and evoked potential testing and intra-operative monitoring. 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.
 
“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.

CareFusion is based in San Diego, Calif.