Advanced Bionics LLC has agreed to pay more than $12 million for allegedly misleading federal health-care programs about the radio-frequency emissions generated by some of its processors for cochlear implant system devices, the Department of Justice said Tuesday.
The California-based company falsely represented that its processors satisfied an internationally recognized emissions standard when submitting its pre-market approval applications to the Food and Drug Administration for its Neptune and Naida cochlear implant processors, according to the DOJ.
Advanced Bionics has entered into a five-year corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human ...
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