Dear AuntMinnie Member,
A U.S. Food and Drug Administration (FDA) panel is meeting today to review the regulation of cardiac ultrasound contrast agents in a sign that the agency is still concerned about the safety of the products.
Debate over the safety profile of echo contrast has raged since the FDA in October 2007 required contrast manufacturers to include a black box warning on the labeling information of the two cardiac agents on the U.S. market. As recently as a month ago, the FDA appeared to be softening its position after cardiac imaging proponents conducted a lobbying campaign in support of echo contrast.
But on Friday, the FDA said it remains concerned about the risks of echo contrast, and the agency's Cardiovascular and Renal Drugs Advisory Committee is meeting today to discuss the topic. The agency said that since its October black box announcement, four more patients have died following administration of one particular agent.
Will the meeting result in renewed oversight of echo contrast? How will the FDA regulate other ultrasound contrast agents not yet approved? We can't answer these questions just yet, but you can learn more by clicking here, or visit our Cardiac Imaging Digital Community at cardiac.auntminnie.com.
VC CAD and radiographers
One of the most intriguing topics in radiology is whether nonradiologists such as radiologic technologists/radiographers should have a role in reviewing medical images, even on a preliminary basis. While the topic is anathema in the U.S., other countries are examining the issue as a strategy for coping with chronic radiologist shortages.
We visit the subject in our Virtual Colonoscopy Digital Community this week by examining a recent clinical study in which U.K. researchers looked at the diagnostic performance of radiographers backed by computed-aided detection software, and compared it to the performance of radiologists.
They found that radiographers had some strengths -- but might not be ready to fly solo just yet. Learn more by clicking here, or visit our Virtual Colonoscopy Digital Community at vc.auntminnie.com.
