Biofield To Submit Revamped PMA For Breast Cancer Diagnosis System
This article was originally published in The Gray Sheet
Biofield is planning to make a second attempt at securing FDA approval for its Biofield Diagnostic Device following the completion of an upcoming clinical trial of the non-invasive tool to evaluate its use as an aid in breast cancer detection.
You may also be interested in...
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
Medical products that do not fully comply with Canadian requirements but are manufactured according to comparable standards are being allowed into the country to deal with COVID-19-related shortages.