Lung nodule screening tool gets backing from FDA panel
The Cancer Information Network
Posting Date: February 15, 2004

New York (The Cancer Information Network) -- An advisory panel of the US Food and Drug Administration has given support to R2 Technology’s computer-aided tool designed to screen for lung modules as a way of detecting lung cancer while at still at an early stage, according to a report by Reuters.

The support from the advisory panel was nearly unanimous, with only one member, who participated in the discussion by conference call, abstaining.

The screening tool is known as the ImageChecker CT-LN 1000 software system. Through computer-aided detection (CAD), it can scan and mark chest images where suspicious areas as small as 4 millimeters wide could indicate the possibility of lung cancer at an early stage.

According to officials of R2 Technology, a California-based firm, CAD has never before been used for Computed Tomography (CT).

Despite the backing that it gave the new technology, however, the advisory panel set conditions for its approval, including a requirement that R2 Technology re-analyze data taking into account the impact the technology will have on individual patients. 

The panelists also cited the need for the proper training of radiologists in the new technology, as well as vigilance on the part of medical practitioners who may be inclined to rely more on technology than on their own trained medical judgment.

The recommendations of advisory panels are usually followed by the FDA, which is expected to reach a decision on the matter within months.