Dear AuntMinnie Member,
Mammography screening is under the microscope again this week with the publication of an editorial opinion in the Journal of the American Medical Association that casts doubt on the effectiveness of breast and prostate screening.
The editorial proposes that 20 years of screening have not produced the expected declines in deaths from these diseases, according to an article by associate editor Kate Madden Yee in our Women's Imaging Digital Community. The JAMA editorial recommends a more "balanced" approach to screening guidelines that also highlights the potential for what the authors called "overdiagnosis and overtreatment" of cancer. Click here for the story.
But does the editorial obscure the evidence behind mammography's value? Some breast imaging advocates believe that the JAMA authors are understating mammography's role in a sharp reduction in breast cancer over the past 20 years. Breast imaging specialist Dr. Daniel Kopans provides his perspective in a Second Opinion article you can reach by clicking here.
GE to buy ONI
In other news, multimodality OEM GE Healthcare of Chalfont St. Giles, U.K., has inked a deal to acquire extremity MRI firm ONI Medical Systems of Wilmington, MA. The deal will give GE access to ONI's MRI technology, designed to offer a more compact option for musculoskeletal imaging than a whole-body scanner. That story is in our MRI Digital Community and can be reached by clicking here.
FDA finally issues CAD rules
Meanwhile, the U.S. Food and Drug Administration this week finally issued long-awaited proposed rules that would govern regulatory submissions for computer-aided detection (CAD) systems.
The draft guidance should help CAD software developers, who have been waiting in limbo since the FDA said in early 2008 that it would revise the guidelines it uses for reviewing regulatory applications for new CAD products. The number of CAD approvals has fallen markedly during the FDA's review.
The good news with the guidance is that vendors now have a road map to use when navigating the FDA's CAD approval process. The bad news is that the agency's proposed rules call for clinical trials and other requirements that are closer to a premarket approval (PMA) application than a less rigorous 510(k) submission.
Learn more by clicking here, or visit our Advanced Visualization Digital Community at av.auntminnie.com.
