R2 Technology, Inc. has launched an upgrade to its ImageChecker CT Lung Version 2.0 CAD software system with the AutoPoint temporal comparison feature for use during review of multislice CT (MSCT) chest exams.
The ImageChecker CT Lung CAD can be used as a standalone device, however the enhancements include expanded PACS (picture archiving and communications system) integration capability and will soon be made available as the only CT Lung CAD option integrated into the Vitrea workstation's CT Lung visualization package, developed by Vital Images, Inc.
The ImageChecker CT Lung CAD helps physicians by increasing their accuracy and efficiency when reviewing the huge number of images created by multislice CT chest studies. To that end, R2 Technology's CT Lung CAD system is the only system of its kind that has been submitted and approved by the FDA under the Pre-Market Approval (PMA) process, R2 Technology said.
The PMA is a very rigorous process in which many companies choose not to participate. The approval "allows [R2 Technology] to make claims of performance that specifically mention nodules. The only claim that could be made with lesser FDA approval, such as the 510 (K), is that we can help radiologists and physicians find spherical objects," John Pavlidis, president and CEO of R2 Technology, told Health Imaging & IT.
Specifics of the clinical research submitted to the FDA include the ability of the ImageChecker CT Lung CAD system to reduce the number of actionable lung nodules missed by radiologists by as much as 26 percent, with a false marker rate of just two per normal case. The FDA therefore approved the conclusion that the CAD software system showed a statistically significant average reader improvement (p=0.003) for detection of solid pulmonary nodules (4mm-30mm), R2 Technology said.
The system is also unique in its ability to help physicians to compare studies throughout the history of a patient's treatment.
"It's not only important to identify nodules, it's also important to track them over time. The AutoPoint feature for temporal comparison compares the most recent study to a selected prior study," said Pavlidis. He continued, "it is the only program that spatially registers the two data sets. So in other words, it truly looks at multiple anatomical landmarks between the two studies, and with high precision, maps the two data sets so that even if the position on the table was slightly different or the breath hold was at a slightly different level, or if the patient has lost weight and so on, it actually does a remarkable job in identifying the same nodule in the two studies. We don't leave it up to guess work."
ImageChecker CT Lung CAD also is designed to lighten the manual work that must be done by a radiologist or physician in evaluating sets of studies.
To do this manually with a calculator for multiple nodules over a period of time is tedious at best. The ImageChecker CT Lung compiles all of data, which improves the accuracy of measurement, according to R2. At the end of the study, a comparison table is provided which contrasts the results from each study, noting differences -- which helps to eliminate misses and tracks previously marked nodules for volume and density changes. It can note, for instance, a nodules doubling time which is important in determining potential malignancy, Pavlidis said.
Lung cancer cases number about 1.2 million cases around the world yearly. It is to blame for 31 percent of the estimated annual cancer deaths in U.S. for men and 27 percent of cancer deaths in U.S. women, according to the World Health Organization and the American Cancer Society (ACS).