FDA asked to approve new US contrast indications

Dear AuntMinnie Member,

Is ultrasound's growth in the U.S. being held back by the Food and Drug Administration's reluctance to approve new indications for ultrasound contrast?

That's the suggestion of an article we're featuring this week in our Ultrasound Digital Community by contributing writer Wayne Forrest. While ultrasound practitioners in other countries benefit from new clinical indications made possible through contrast enhancement, practitioners in the U.S. continue to limp along with just one FDA-approved indication -- left ventricle imaging.

Ultrasound contrast has a number of advantages -- it's cheap, lacks the ionizing radiation of modalities like CT, and can rule out the need for more invasive tests. Regarding its clinical efficacy, European researchers are discovering that ultrasound with contrast enhancement is capable of performing at a level equivalent to more expensive modalities like MRI and CT.

The FDA has a number of concerns regarding ultrasound contrast that may have made the agency reticent to approve new indications. But many ultrasound proponents believe these fears are overblown, and are working to educate the FDA on the importance of expanding the number of approved ultrasound contrast applications. Learn about what they're doing by clicking here.

In another recent article we're featuring in the community, U.S. researchers found that using ultrasound and mammography together in pregnant women diagnosed with breast cancer added additional clinical information as opposed to mammography alone. Read about that study by clicking here, or visit the Ultrasound Digital Community at ultrasound.auntminnie.com.

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