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Biofield Petitions for Less Burdensome Route For Breast Cancer Diagnostic

This article was originally published in The Gray Sheet

Executive Summary

Biofield Corp. expects to hear from FDA within 60 days regarding a de novo petition for reclassification of its investigational breast cancer diagnostic device to Class II status

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Biofield BDS resolution

"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)...

Biofield BDS resolution

"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)...

Biofield To Submit Revamped PMA For Breast Cancer Diagnosis System

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