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China's FDA approves laser breast imaging device.

Women's Health Weekly

| November 04, 2004 | COPYRIGHT 2004 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2004 NOV 4 - (NewsRx.com & NewsRx.net) -- Imaging Diagnostic Systems, Inc., (IMDS) announced that its CT Laser Mammography system (CTLM) has received Chinese State Food and Drug Administration (SFDA) marketing approval.

Following extensive inspection, the Peoples Republic of China SFDA issued the registration "Certificate for Medical Device," representing the first approved laser-based breast cancer detection system in China. The medical device registration number is 20043241646.

"The SFDA approval of our device is a major step in our global commercialization program. China is an enormous market for cancer detection devices since cancer became the leading cause of death in 1966. There has been a steep increase in the number of lung, breast, and colon cancers, according to the Globoscan 2000 database," stated Tim Hansen, CEO of Imaging Diagnostic Systems.

"CTLM patient acceptance should be high because it uses no harmful radiation, just laser light, and the procedure is painless for the woman since there is no compressing or even ...

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Source: HighBeam Research, China's FDA approves laser breast imaging device.

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