Biofield BDS resolution
This article was originally published in The Gray Sheet
Executive Summary
"Breast proliferation rate detection system" is Class III, requiring premarket approval, according to FDA, the firm announces March 9. In January, Biofield petitioned for downclassification of the system, which uses electrical signals to evaluate lesions as an adjunct to breast imaging procedures (1"The Gray Sheet" Jan. 17, 2005, p. 38)...