FDA Clears Digital Mammography Technology from Fischer Imaging and R2 Technology
Dec 2, 2003
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Fischer Imaging Corporation, a developer of digital mammography imaging systems, and R2 Technology, Inc., a developer of computer-aided detection (CAD) technology, announced that clearance has been granted by the U.S. Food and Drug Administration (FDA) for the use of R2's proprietary mammography CAD technology with Fischer's SenoScan(R) digital mammography system.
Under a development and marketing agreement, Fischer Imaging has integrated R2's CAD technology into its SenoScan system and has exclusive distribution rights to the integrated system.
According to Fischer, its SenoScan product, which has been FDA cleared since Fall 2001, is the first digital mammography system to offer 25-micron native resolution -- said to be the highest resolution available in the digital mammography industry. The company said its patented slot-scanning technology is the only FDA-cleared digital mammography scanning system that can produce digital mammograms at less than half the dose of other mammography systems -- film or digital.
The agreement also states that R2 Technology's ImageChecker DM analog system, which received FDA clearance in September 2003, also will support CAD analysis of digital images acquired on the SenoScan system. The ImageChecker DM System will be distributed directly by Fischer and R2.
Fischer says the combination of the dedicated digital and hybrid CAD products enables it to provide a complete CAD solution.
"We are pleased to be able to offer radiologists this innovative technology to assist in the early detection of breast cancer," said Harris Ravine, CEO for Fischer Imaging. "Since we began working with R2 Technology on the integration of CAD with the SenoScan system, we've felt this partnership would result in a world class solution offering a powerful tool in the fight against breast cancer."
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