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FDA accepts fourth module for angiogenesis-based imaging system.(United States Food and Drug Administration )(Brief Article)
2002 NOV 21 - (NewsRx.com & NewsRx.net) -- DOBI Medical Systems, LLC, announced that the U.S. Food and Drug Administration (FDA) has accepted the fourth module of its premarket approval (PMA) application for its Dynamic Optical Breast Imaging System, called ComfortScan.
The fourth module, submitted in 2002, is part of the company's five-module submission plan previously accepted by the FDA. DOBI Medical Systems is seeking FDA approval for its noninvasive breast imaging system to be used as a new tool to aid mammography and other diagnostic techniques in improving the accuracy of breast cancer diagnosis.
The ComfortScan System identifies angiogenesis, or vascular changes, in the breast as a new means to help physicians more effectively differentiate malignant from benign tumors.
DOBI Medical Systems is using the FDA's modular-submission approach, which divides the traditional PMA application into modules. This allows progressive review and acceptance of each modular portion of the total data required, thus facilitating the ...
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Source: HighBeam Research, FDA accepts fourth module for angiogenesis-based imaging...