CHICAGO - The mammography market could soon see a new competitor in the computer-aided detection (CAD) niche. Canadian developer CADx Medical Systems this week received an approvable letter from the FDA for its Second Look CAD system. Once final premarket approval (PMA) is received, CADx will join R2 Technology as one of two companies able to market a CAD system in the U.S.
CADx’s technology is based on pattern recognition algorithms first developed to enable U.S. fighter planes to detect Iraqi military equipment during the Persian Gulf War. CADx licensed the technology from its original developers, Qualia Computing of Beaver Creek, OH. CADx has an exclusive license to the technology for medical applications.
Second Look works by analyzing digitized mammograms and applying computer algorithms that examine microcalcifications and masses according to 16 different "classifiers," or characteristics found to be common among cancerous tissue. One classifier is mass shape, for example.
After analysis, suspicious areas are highlighted, and the study is output to a plain-paper printout that radiologists can use to reexamine the original films for suspicious areas they may have missed, according to Peter Farrell, director of marketing for the Laval, Quebec company. Clinical trials with the system indicate that it can increase the detection rate for missed cancers by 21%, with only a 0.5% increase in the diagnostic workup rate, he said.
The FDA approvable letter applies only to the use of the system with digitized mammography films, as opposed to digital data from a full-field digital mammography system (FFDM). In its RSNA booth, CADx is demonstrating Second Look AD, a work-in-progress second-generation system that can accept either digitized or FFDM data via a CD-ROM or PACS, and transfer analyzed images back to a CD-ROM or PACS using the DICOM standard. CADx declined to estimate when Second Look AD would be commercially available.
The company also hopes to commercialize a newer version of the current Second Look system that can send digitized mammogram data back to a PACS. That system is already being sold outside the U.S, but will require the filing of a supplemental PMA to the product’s existing application before U.S. sales can begin, Farrell said.
CADx expects to receive final approval once the company has finalized the system’s product labeling with the FDA, which could take a month or two. CADx will sell the scanner directly, and is hiring a sales force of 16 people to market the unit. The company also has OEM alliances with mammography vendors Lorad of Danbury, CT, and Fischer Imaging of Denver. Those companies are able to sell Second Look as part of a bundle with their mammography systems.
Although mammography reimbursement has been under pressure, CAD is reimbursable by Medicare at a rate of $17.74 per study. At this level, a facility could break even at 12-15 studies per day, Farrell said. Although the company can’t release U.S. pricing until final FDA approval is in hand, the system sells for the equivalent of $169,000 internationally.
By Brian Casey
AuntMinnie.com contributing writer
November 28, 2001
For the rest of our coverage of the 2001 RSNA meeting, go to our RADCast@RSNA 2001.
Copyright © 2001 AuntMinnie.com
