In short
CareFusion has announced clearance from the U.S. Food and Drug Administration (FDA) for its new Viking on Nicolet® EDX electrodiagnostic system under the 510(k) approval process. The company describes the EDX system as a multi-modality device for monitoring and testing electrophysiological information from the human nervous and muscular system.
Background
According to a press release from Carefusion, 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 reduce costs.
More product information can be found here.
Company comments
“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.”
Availability
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.
SOURCE CareFusion, PR Newswire
published: March 20, 2012 in: Approval/Clearance, Congresses and Meetings, Launches / Withdrawals, Neuro, Regulatory