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Home » CareFusion lands 510(k) for next-gen electrodiagnostic system | Regulatory Roundup

CareFusion lands 510(k) for next-gen electrodiagnostic system | Regulatory Roundup

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MassDevice.com Regulatory Roundup

 CareFusion touts FDA OK for Viking on Nicolet EDX system
San Diego, Calif.-based medical device maker CareFusion (NYSE:CFN) won FDA clearance for its Viking on Nicolet electrodiagnostic system, a multi-modality device that monitors and tests the body’s electrophysiological functions.

The next-gen EDX system provides feedback in a variety of reporting formats for nerve conduction studies, electromyography, evoked potential testing and intra-operative monitoring, according to a press release.

The FDA nod is more good news for CareFusion, which this month won a $75 million contract from the U.S. Defense Dept. and won an honorable mention on CNN Money’s list of the most admired companies, and last month touted a $44.7 million DOD contract for infusion pumps.

The regulatory win didn’t do much for CareFusion on Wall Street, however, where CFN shares were down 1¢ to $25.65 as of about 2:45 p.m. today. Read more

 Tearson and Soma Access win 510(k) for jointly developed transducer with AxoTrack needle visualization

 SpinalMotion lands CE Mark for 2 Kineflex cervical disc implants

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