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Kodak gets FDA approval for mammography device.
2003 DEC 4 - (NewsRx.com & NewsRx.net) -- Eastman Kodak Co., which is expanding its health imaging business as its main photography business fades, said that its new breast cancer detection device has drawn qualified approval from the U.S. Food and Drug Administration (FDA).
The computer-aided mammography device uses algorithms to highlight suspicious areas on patients' digitized images that radiologists then examine more closely for possible disease.
Clinical trials determined that 39% of missed breast cancers might have been detected almost 15 months earlier using its technology, Kodak said.
The company said the FDA sent an "approvable letter" for the device, a precursor to final marketing approval. The company's manufacturing practices must now pass an agency review.
The technology is based on disease-detection software Kodak acquired in September 2003 from MiraMedica Inc. of Los Gatos, California. MiraMedica was created in 2001, and the software emerged from ...
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Source: HighBeam Research, Kodak gets FDA approval for mammography device.