Kodak Submits Final Clinical Data to FDA for Approval of CR System for Mammography
ROCHESTER, N.Y., November 9 -- Eastman Kodak Company announced it has submitted the final module of a pre-market approval submission (PMA) to the U.S. Food and Drug Administration for approval of its computed radiography system for mammography.
The final module contains data and test results from the clinical trials Kodak has concluded at several sites in the U.S. and Canada. The FDA has already accepted and closed review of the previously submitted modules covering manufacturing information and non-clinical data.
The FDA filing is on track with Kodak’s plan for obtaining regulatory approval in the U.S., so that when approved, the company may begin selling its KODAK DIRECTVIEW CR Mammography Feature in the U.S. next year.
“I look forward to this technology being able to provide the convenience of digital imaging in many healthcare facilities which may not otherwise have access to digital mammography,” said Dr. Sughra Raza, Director Women’s Imaging Program, Department of Radiology, Brigham & Women’s Hospital. Dr. Raza participated in the clinical trials for Kodak’s CR for mammography feature.
Kodak’s CR (computed radiography) mammography feature will offer the ability to produce high-resolution scans for mammography applications (50 microns per pixel—or 20 pixels per millimeter) when using KODAK DIRECTVIEW CR Mammography Cassettes and EHR-M screens. High-resolution images are critical for helping radiologists identify breast cancer in women who may have no obvious signs of the disease.
This innovative feature will enable mammography images to be captured digitally with Kodak’s CR systems while continuing to use these systems for general radiography exams. This optional feature for KODAK DIRECTVIEW CR 850/950/975 Systems will be available when purchasing a new KODAK CR system or as a retrofit to previously installed KODAK systems.
Kodak’s mammography feature is already being sold in Europe, Greater Asia, Japan and Latin America, and Kodak has installed hundreds of systems with this feature in facilities ranging from small clinics and breast imaging centers to large hospitals and medical centers.
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.
- Contact Information
- John LaBella
- Global, North America Contact, Health Group Products
- Eastman Kodak Company
- Contact via E-mail
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