Fischer Imaging Receives Final FDA Approval For SenoScan.(SenoScan Full Field Digital Mammography System)

2001 NOV 8 - (NewsRx.com & NewsRx.net) -- Fischer Imaging Corp. (FIMG), which manufactures digital mammography and medical imaging systems, has received final U.S. Food and Drug Administration (FDA) approval to market its SenoScan Full Field Digital Mammography System.

"This final FDA clearance of our SenoScan Full Field Digital Mammography System presents a tremendous market opportunity for Fischer Imaging and I am proud that we have reached this milestone," said Louis E. Rivelli, president and chief executive officer of Fischer. "Breast screening is a growing multibillion dollar industry and our market data indicates that worldwide, there are about 30,000 film screen mammography systems currently installed. Over the coming years a large portion of these systems will be replaced with digital mammography systems such as the SenoScan, with the conversion rate reaching as high as 1,500 systems per year by 2007. There is currently only one other direct competitor in this market segment, and with the SenoScan as our flagship product, we will aggressively pursue this market. Given the data available, even a small penetration into the digital mammography marketplace will have substantial impact on the growth of our company.

"Over the last year and a half, all Fischer employees, customers and shareholders have been anticipating this moment. With SenoScan we intend to leverage every opportunity to gain market share in the screening and diagnostic segments of breast care," Rivelli noted. "Obtaining FDA approval of this product under the difficult and stringent PMA review process provides testimony to the evolution of Fischer to a world-class organization, and is the direct result of intense focus and commitment to our core competency of breast care. Following the sale of five SenoScan systems to institutions participating in the recently announced NCI/ACRIN Study, this final marketing approval will now allow us to focus on converting a pipeline of interest in our product to hard sales."

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