The Food and Drug Administration has asked breast technology developer Biofield to conduct more clinical testing in support of a regulatory submission for its Breast Cancer Detection System.
Biofield had held a meeting with the FDA to review data in the company's recently submitted 510(k) application, with the goal of streamlining the eventual submission of the company's premarket approval (PMA) application for the product. The FDA, however, said the data in the 510(k) was insufficient for several reasons and asked for more clinical testing.
By AuntMinnie.com staff writers
July 25, 2005
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