U.S. sales are still at least a year away, as firm prepares PMAA new computer-aided diagnosis (CAD) workstation called ImageChecker is now being sold on the European market, according to executives at R2 Technology, the Los Altos, CA, firm that
U.S. sales are still at least a year away, as firm prepares PMA
A new computer-aided diagnosis (CAD) workstation called ImageChecker is now being sold on the European market, according to executives at R2 Technology, the Los Altos, CA, firm that developed the product. Sales of the system in the U.S. could be at least a year away, however, as the company plans to use the rigorous premarket approval (PMA) process to gain regulatory clearance for the product.
R2 Technology has developed software that uses computer algorithms to detect suspicious areas in breast images (SCAN 10/20/93). Mammography films are first read by a mammographer, who makes a preliminary interpretation without help from the computer. The mammographer can then activate ImageChecker, which highlights suspicious areas on a digitized mammogram.
The CAD software detects possible abnormalities in the breast, such as microcalcifications or mass lesions, and alerts the mammographer by inserting a notation on the workstation display screen that points to the suspicious area. The mammographer can then alter his or her interpretation of the mammogram depending on the suggestions of the CAD program. The system, which is based on work done at the University of Chicago and other locations, is designed to provide a "second read" that can reduce errors by providing a back-up to mammographers.
ImageChecker sales began in the first quarter in Europe, according to Bob Wang, chairman of R2. Under European regulatory law, the system is classified as a class I device, which allows companies to begin marketing the device through a self-certification process. CE Mark certification is expected in the next several months, once internal paperwork is completed.
R2 has entered ImageChecker into several European clinical trials to prove the utility of the product. One study has been completed at the University of Nijmegen in the Netherlands to compare the reading accuracy of ImageChecker and one radiologist to that of two radiologists. The results of that study are being analyzed. The university is the center for screening mammography in the Netherlands, according to Wang.
In addition, a paper was presented at the European Congress of Radiology in Vienna last month based on investigations done at the University of Jena in Germany, where researchers found that ImageChecker could help detect cancer at an earlier stage.
R2 plans to sell ImageChecker directly in Scandinavia, which should be a good market for the system because patient compliance with screening guidelines is higher than in other regions in Europe, Wang said. The company is soliciting distributors for other countries in Europe, and displayed ImageChecker at the ECR to drum up interest in the product.
The list price of ImageChecker will be about $150,000, which includes a laser digitizer, software, and three Intel Pentium 166-MHz computers, which are used for image digitizing, processing, and display.
ImageChecker's fast road to market in Europe relative to the U.S. is due to the different regulatory philosophy taken by European officials compared with the Food and Drug Administration. While ImageChecker and other CAD products can be marketed in Europe with vendor self-certification, the FDA has taken a more hands-on approach. R2 Technology plans to conduct clinical trials in preparation for a PMA submission to the FDA, which could occur as soon as the fourth quarter of this year. The FDA has granted ImageChecker expedited review status, which should hasten the product's arrival on the U.S. market.
While going the PMA route will take longer than filing a less rigorous 510(k) application, there will be some advantages for R2, according to Wang. For one, it will force other companies with mammography CAD programs to go the PMA route as well, and Wang believes that this will raise a significant barrier to entry to potential competitors.