In Brief: Biofield
This article was originally published in The Gray Sheet
Biofield: Plans to wrap up ongoing discussions with FDA within the next two to three months regarding the protocol for a proposed limited confirmation study of the Atlanta firm's breast cancer diagnosis system, the Biofield Diagnostic Test, formerly called the Alexa 1000. Results of the study would be submitted to provide additional support to a premarket approval application deemed not fileable by FDA in February ("The Gray Sheet" March 10, In Brief). Biofield says the proposed study "is expected to include not less than 300 to 400 patients with previously identified breast lesions"...
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