CVR Medical Corp. announced it has completed a Food and Drug Administration De Novo Submission for their 'Carotid Stenotic Scan (CSS)' device. A De Novo Submission allows for a company to receive a 'not substantially equivalent' risk-based evaluation for any legally marketed device for which there is no prior, comparable classification. As a novel device that uses patented sound wave analysis technology to detect and measure carotid arterial stenosis, the CSS fits within the criteria of this FDA filing. Due to US government shutdown, the submission will be reviewed by the FDA upon resumption of government activity.