VC offers 2-for-1 density screening; FDA makes headlines

Dear AuntMinnie Member,

If you had an imaging exam that reliably screened for two diseases in a single study -- two diseases that are perennially underscreened, at that -- you'd offer it in your practice, right?

Virtual colonoscopy proponents believe they have such an exam in their arsenal. New research indicates that the CT data acquired in a typical VC study can be used to produce accurate bone mineral density (BMD) measurements for osteoporosis screening.

Researchers from the University of Wisconsin found that VC-based BMD scores correlated well with data from the gold standard for osteoporosis screening, dual-energy x-ray absorptiometry. See their results by clicking here, or visit our Virtual Colonoscopy Digital Community.

FDA makes headlines

In other news, multiple breaking stories are coming out of the U.S. Food and Drug Administration (FDA) this week.

First off, the FDA yesterday announced long-awaited changes to its regulatory process for medical devices. Agency observers believe the moves should streamline the process for most products, but the agency punted on some bigger issues, according to at least one consumer advocate. Learn more by clicking here.

There are also two big FDA hearings this week on regulatory applications for radiopharmaceutical and contrast media products. Today, the FDA is scheduled to review Eli Lilly's application for Amyvid (florbetapir), a PET radiopharmaceutical for detecting early signs of Alzheimer's disease.

FDA reviewers are said to have some concerns about the clinical benefits of the agent, but a new study published this week in the Journal of the American Medical Association found that Amyvid detected signs of the early onset of Alzheimer's. Click here for that article, and check back in the Molecular Imaging Digital Community for coverage of the FDA meeting.

On Friday, the FDA will review an application by Bayer HealthCare Pharmaceuticals for Gadovist (gadobutrol), a new MRI contrast product. Top on the agenda will be a discussion of the risk of nephrogenic systemic fibrosis, which has been linked to gadolinium-based contrast agents. Learn more in our MRI Digital Community by clicking here.

Page 1 of 436
Next Page