A computer-aided system that can detect little nodules in the lung just as they become cancerous won approval Monday from the Food and Drug Administration.
The image analysis system — a sophisticated version of computer software — will help analysts find nodules using computer tomography, or CT, images of the lung.
The ImageChecker CT-LN 1000 is made by privately held R2 Technology Inc. of Sunnyvale, Calif. It automatically searches for suspicious areas in CT scans.
While such small, knobby masses can be benign, they can also indicate lung cancer. Other conditions a patient may have had, such as tuberculosis, fungal infections and blood clots, can also form nodules.
“Computer-aided detection acts as a second pair of eyes for the radiologist and is used after the radiologist first conducts a standard review,” the company said in a statement.
Biggest cancer killer in developed world
Lung cancer is by far the biggest cancer killer in the developed world. It affected 171,000 Americans last year and killed 157,000, according to the American Cancer Society.
More than 1.2 million cases of lung cancer were reported worldwide last year.
Doctors say one reason it is so deadly is that lung cancer is often not detected until it has spread.
In 2000, the five-year survival rate lung cancer in the United States was 14 percent, but this figure rises to 42 percent if the cancer is found in its earliest stages, when the tumor can be completely removed.
The FDA said its approval was based on a clinical study presented by R2.
“In the study, 15 radiologists independently reviewed 90 images from lung CT scans without the ImageChecker system, and then again using the new system,” the FDA said in a statement.
“When radiologists used the new system, they were able to identify more nodules than they could without it, improving their ability to detect lung nodules that require further evaluation.”
In Europe, the ImageChecker CT-LN 1000 began commercial use in March 2003.
