FDA officials: 3-D imaging technologies poised for breakthrough

The U.S. Food and Drug Administration has issued a consumer update detailing how the development of 3-D technologies are poised to change cancer detection.

According to the FDA, scientists in the agency's Division of Imaging, Diagnostics, and Software Reliability are studying how doctors receive visual information in order to analyze and diagnose disease. They specifically are focusing on breast cancer screening devices that incorporate 3-D technology, such as tomosynthesis, 3-D ultrasound and breast CT.

"Other industries are developing displays and fast computers that can be incorporated or utilized in [medical] images," Mary Pastel, deputy director for radiological health in the FDA's office of in vitro diagnostics and radiological health, told the Washington Post. "The challenge for the FDA and industry is, at what point are those kinds of devices effective enough for the unique challenge of displaying medical images? Certainly Pixar images in movies can be moving toward quite realistic rendering, but there are substantial challenges displaying medical images with a very high pixel [rate]."

In the case of tomosynthesis, the FDA has approved just two systems for sale in the U.S.: the Selenia Dimensions 3-D System, which provides 3-D tomosynthesis images of the breast for cancer diagnosis, and the GE Healthcare SenoClaire, which uses a combination of 2-D mammogram images and 3-D breast tomosynthesis images.

According to the Post, the FDA is looking for ways in which the approval process for these new technologies--which can be rather cumbersome--can be expedited.

"Our ultimate goal is to develop a thorough enough [process] to shift our burden of evidence to the physics [of the device], and rely less and less on the requirement of a clinical study," Kyle Myers, director of the FDA's division of imaging, diagnostics and software reliability, said.

Tomosynthesis added to digital mammography is associated with an increase in the detection of breast cancers as well as a decrease in call-back rates, according to a study published in June in the Journal of the American Medical Association.

To learn more:
- see the FDA update
- see the article in the Washington Post