The FDA’s Radiological Devices Panel of the Medical Devices Advisory Tuesday convened in Gaithersburg, Md., to hear testimony from industry experts about the effectiveness of computer-aided detection (CAD) and diagnosis. The meeting concludes today.
The intention behind using CAD is to call out suspicious areas on mammograms during breast cancer screenings that might otherwise go unnoticed.
Many in the radiology community also have expectations that the two-day dialogue will produce results to alleviate the current regulatory application bottleneck for CAD software and make recommendations for how CAD should be evaluated for approval in the United States.
According to the Feb.7 issue of the Federal Register, discussion will focus on “the general methodologies for CAD, including how CAD devices are used in clinical decision-making, how the devices are tested, and the information needed to properly assess their safety and effectiveness.”
The panel will also focus its attention on mammography CAD devices, colon CAD devices and lung CAD devices during the meeting, including how the different types of CAD devices are used and the literature published regarding these devices, with focus on testing issues related to the different devices.
The FDA intends to post background material on its website after the meeting.