WASHINGTON (dpa-AFX) - CareFusion (CFN) said it has received 510(k) clearance from the U.S. Food and Drug Administration, or 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, CareFusion noted.
In addition, EDX system helps enhance 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.
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