Biofield to try again with FDA

Breast cancer diagnosis developer Biofield has met with the U.S. Food and Drug Administration as a first step towards renewing efforts to obtain clearance for its Biofield Diagnostic System. The system, which measures electrical changes in cells as they divide, allows users to identify the abnormal division of cancer cells, according to the Atlanta-based vendor. The FDA declined to accept the company's premarket approval application in 1997 because it said clinical trials in support of the product were flawed.

During the meeting with the FDA, Biofield discussed data it has obtained on over 1,500 women analyzed for breast cancer with its BDS. The data will be used in an updated application to the FDA, according to the vendor. BDS has received the CE Mark for marketing in the European Union.

By staff writers
September 18, 2001

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Biofield begins Europe survey, August 31, 2000

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