Women's Health Weekly
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Breast Cancer
Reclassification sought for Biofield diagnostic system
February 10th, 2005
Biofield Corp. (BZET), developer of the Biofield Breast Proliferation Rate Detection System (BDS), a non-invasive, radiation-free adjunctive test system that may be of assistance in the evaluation of suspicious breast lesions, announced that it has submitted a petition to the U.S. Food and Drug Administration (FDA) requesting reclassification of the BDS. The petition requests reclassification of the BDS and other devices in the same category from class III status, requiring premarket approval, to class II status permitting clearance through the less burdensome 510(k) process based on the application of general and special controls designed to assure safety and...
Source: Women's Health Weekly (2005-02-10)
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