FDA nod clears first lung CAD technology product

July 16, 2004

R2 Technology, a perennial leader in the development of computer-aided detection technology, has received premarket approval from the FDA to sell its ImageChecker CT CAD software in the U.S. An executive for the Sunnyvale, CA, company said marketing

R2 Technology, a perennial leader in the development of computer-aided detection technology, has received premarket approval from the FDA to sell its ImageChecker CT CAD software in the U.S. An executive for the Sunnyvale, CA, company said marketing would begin immediately.

ImageChecker CT CAD is the first CAD product the FDA has approved for the detection of solid lung nodules during review of multislice CT chest exams. Being first gives R2 a distinct advantage, said Susan Wood, vice president of CT products for the firm.

"We have the first-mover advantage to provide a solution to a problem that radiologists have been telling us about. That problem is having too much information," she said. "Our product gives them the means to distill the information, so that they can make a more accurate diagnosis."

R2 believes it will have the only marketable product through at least the remainder of 2004. The company expects to ship about 25 by the end of the year.

As with other R2 products, ImageChecker CT CAD is intended for use after physicians have done the primary reading. CAD algorithms are designed to provide a computerized "second reading," automatically pointing out potential areas of interest. The objectives are to reduce the rate of missed lesions and to increase physician accuracy, particularly in the detection of solid lung nodules.

"We've positioned the product to work for all diagnostic chest exams and for screening," Wood said. "To our software, lung nodules-whether detected as part of a screening or part of a diagnostic exam-look the same. So it's up to purchasers how they want to use the software."

R2's product will provide a financial benefit to users by improving the diagnostic process, Wood said, even though there is no incremental reimbursement for the use of lung CAD.

"Radiologists are being inundated with more and more information," she said. "This device is targeted to increase their accuracy . . . and cut down on their reading time."

The system can be integrated with hospital PACS or CT scanners. While not yet bundled with any CTs, ImageChecker CT CAD can be purchased as an option, Wood said. Installed systems can also be upgraded to include the CAD tool.

ImageChecker CT CAD will be marketed initially to large hospitals that have multiple CT scanners and perceived workflow inefficiencies. Independent radiology centers also will be targeted.

With an estimated 1.2 million new cases each year, lung cancer represents a substantial clinical need. According to the American Cancer Society, many early-stage lung cancers are diagnosed incidentally as a result of imaging studies requested for unrelated medical conditions. Lung CAD software may be well suited for helping to catch these cancers.