R2 Technology has received an additional approval from the U.S. Food and Drug Administration that expands the applications for the company’s ImageChecker computer-aided diagnosis (CAD) technology. Last month the agency approved ImageChecker for use with data from full-field digital mammography systems manufactured by GE Medical Systems, R2’s marketing partner.
The approval applies to the use of ImageChecker with Senographe 2000D FFDM units from Waukesha, WI-based GE. The firm is still waiting for a separate FDA approval that would allow it to display the R2 CAD markings on its workstation. For its part, R2 of Los Altos, CA, will need additional approvals to add FFDM systems from other vendors to the original ImageChecker premarket approval (PMA) application.
The approval should result in real workflow improvements for users of the FFDM version of ImageChecker. Prior to the November 13 approval, ImageChecker was authorized to work only with digitized mammography films. In its FFDM configuration, the unit is a workstation that resides on a GE network, and can receive mammography data directly, rather than requiring an additional film digitization step.
R2 discussed the approval at last week's RSNA meeting, and also highlighted a number of other new products in development. For example, CheckMate Ultra is a new feature that enables users to determine why ImageChecker has highlighted a region of interest as suspicious. When a user touches the screen, CheckMate Ultra magnifies and displays the features that led the workstation to highlight the area. The technique was shown as a work-in-progress at RSNA, and will be included in the next version of ImageChecker's software.
R2 is also making inroads into applications outside of breast imaging, with the goal of being a radiology facility's sole provider of CAD functions. Lung cancer screening is the next major target, and the company demonstrated LungCheck in its RSNA booth as a work-in-progress.
Working directly with DICOM-formatted CT data, LungCheck applies R2's CAD algorithms to detect areas that could be pulmonary nodules, and highlights them for further review by a radiologist. Clicking on a highlighted area generates a 3-D image -- a departure from ImageChecker, which deals strictly in 2-D.
LungCheck handles both current and prior images, enabling radiologists to generate quantitative data on radiopacity and volumetric measurements. The feature is useful for measuring treatment response or tumor progression following screening by matching current and prior nodules, according to Susan Wood, director of CT products at the company.
LungCheck is installed at two beta clinical sites, and the company is in discussions with the FDA regarding a regulatory submission. Like ImageChecker, the application will probably require a PMA, Wood said. LungCheck could be part of a stand-alone R2 CAD workstation, or integrated into a third-party image review workstation.
R2 sees the CT market as very promising for CAD applications. In terms of the dollar value of device sales, the CT market is four times as large as the mammography market. R2 hopes to ride a wave of interest in CT screening, according to the company.
At present, only one company, Deus Technologies of Rockville, MD, has FDA approval for a lung CAD device. The company’s RapidScreen RS-2000 product works with projection chest radiography.
Another nonbreast product on display in R2’s RSNA booth was a lung-screening product that R2 is developing for projection chest x-ray. That system would take data from a computed radiography or digital radiography system, and R2 has a co-development relationship with Eastman Kodak Health Imaging of Rochester, NY, for a product that would work with Kodak CR and DR products. That system is about 12-18 months away from FDA approval, according to the company.
By Brian CaseyAuntMinnie.com staff writer
December 6, 2001
Related Reading
CAD cuts false negatives, increases sensitivity of breast imaging, November 28, 2001
R2 Technology installs 200th mammography CAD system, October 22, 2001
CAD wins over mammographers, October 10, 2001
Computer system helpful in interpreting mammograms, September 20, 2001
New CPT code could open door for greater CAD adoption, July 31, 2001
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