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Breast Cancer

Kodak gets FDA approval for mammography device

Published in Women's Health Weekly, December 4th, 2003

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...

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