Radiation Risks Of Interventional Fluoroscopy Examined At FDA Meeting
This article was originally published in The Gray Sheet
Executive SummaryThe use of fluoroscopic imaging during interventional procedures such as cardiovascular catheterizations raises unique radiation exposure issues that must be examined apart from those for diagnostic imaging
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FDA plans to accept a declaration of conformity to an international standard for fluoroscopic equipment even though it does not perfectly the match the performance standard found in FDA regulations, the agency said in draft guidance.