Kodak Begins Submission Process with FDA for Approval of Digital Imaging System for Mammography
ROCHESTER, N.Y., Nov. 17 -- Eastman Kodak Company announced it has begun the process for obtaining U.S. Food & Drug Administration (FDA) approval to market a digital medical imaging system for mammography in the United States.
Following required regulatory procedures, Kodak submitted information to the FDA on the manufacturing of its computed radiography (CR) system for mammography and on analytical tests the system has undergone.
The filings are part of Kodak’s plan for enhancing its current CR systems—which are increasingly used as an alternative to conventional x-ray film—with a special feature intended to offer the ability to produce mammography images. This goal of this feature is to offer sharp and detailed images required for mammography. Additionally, CR systems can process medical images in minutes, speeding results to physicians and patients. The systems also enable medical facilities to better manage patient workloads, thus enabling greater operational efficiency and shorter wait times for patients.
Kodak currently is conducting clinical trials of its digital mammography system at several sites in the U.S. and Canada, which are required for obtaining regulatory approval in both countries.
Hundreds of medical institutions outside the U.S. and Canada already have installed KODAK DIRECTVIEW CR 850, CR 950 and CR 975 Systems with the innovative mammography feature. This optional feature became available in Europe, Greater Asia, Japan and Latin America earlier this year.
CR for mammography is part of Kodak’s broad portfolio of digital solutions for mammography that includes CAD (computer aided detection), PACS (picture archiving and communication systems) and a laser imaging system with special software for printing digital mammography images.
About Kodak’s Health Group
Kodak’s Health Group, with 2004 revenues of $2.68 billion, supplies the medical and dental professions with traditional and digital imaging and information systems. Its portfolio includes picture archiving and communications systems (PACS), radiology information systems (RIS), IT solutions, clinical information solutions, computed and digital radiography systems, laser imagers, mammography systems, x-ray film systems, and dental imaging products. Its services portfolio includes everything from repair and maintenance, to professional services encompassing integration, storage and archiving, secure e-mail services – and much more.
Kodak’s other major businesses include: Graphic Communications – providing customers with a range of solutions for prepress, traditional and digital printing, and document scanning and multi-vendor IT services; Digital & Film Imaging Systems – providing consumers, professionals and cinematographers with digital and traditional products and services; and Display & Components – supplying original equipment manufacturers with imaging sensors as well as intellectual property and materials for the organic light-emitting diode (OLED) and LCD display industries.
KODAK and DIRECTVIEW are trademarks of Eastman Kodak Company.
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- Eastman Kodak Company
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