Medical Letter on the CDC & FDA
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Clinical Trials
ComfortScan PMA clinical trial progresses
October 23rd, 2005
DOBI Medical International, Inc., (DBMI.OB) has added its 20th trial site to its premarket approval (PMA) clinical trial studying its Dynamic Optical Breast Imaging (DOBI) system. The results of the clinical trial will serve as the basis for the PMA application to the U.S. Food & Drug Administration (FDA). The company has contracted with three more sites and is in discussion with several others. Michael Silver, PhD, vice president of clinical research at DOBI Medical International, said, "We continue to make progress toward our goal of completing our clinical trial, the subject of the fifth module and final submission towards...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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