Women's Health Weekly
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Breast Cancer
Breast cancer diagnostic system recommended for FDA approval
December 23rd, 2004
Biofield Corp. (BZET), developer of the Biofield Breast Cancer Diagnostic System (BDS), announced that it has received from KEMA Registered Quality, Inc., a review of the company's 510(k) notification of intent to market the BDS in the United States, and its submission to the U.S. Food & Drug Administration (FDA) of its recommendation for clearance of the BDS to the FDA. KEMA has recommended to the FDA that the device is "substantially equivalent to devices marketed in U.S. interstate commerce prior to May 26, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provision of the Federal Food, Drug,...
Source: Women's Health Weekly (2004-12-23)
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