AirMarshall Posted September 6, 2006 Share Posted September 6, 2006 http://news.yahoo.com/s/nm/20060906/hl_nm/cyberonics_dc The watchdog group Public Citizen is calling for the FDA to remove approval of the Cyberonics Vagus Nerve Stimulating device recently introduced for treatmenent of refractory depression. The group claims that the company has failed to show that the product is safe and effective as required by FDA regulations. Additionally they are calling on Medicare to deny reimubursement, which is currently under consideration. Republican Sen. Charles Grassley, chairman of the Senate Finance Committee, reported that a single FDA administrator approved the device against the objections of 20 FDA doctors, scientists and administrators. The VNS device costs about $25,000. Of note, Cyberonics is currently facing an SEC probe, and de-listing of its stock from NASDAQ for irregularities in its stock options. a.m. Link to comment Share on other sites More sharing options...
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