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DOBI Medical Receives FDA Module Two Acceptance For ComfortScan.(Dynamic Optical Breast Imaging System)

Women's Health Weekly

| November 08, 2001 | COPYRIGHT 2001 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2001 NOV 8 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has accepted the second module of DOBI Medical Systems' Pre-Market Approval (PMA) application for its Dynamic Optical Breast Imaging System, called ComfortScan. This module was submitted in June and is the second of five modules to be submitted, according to the company's modular submission plan previously approved by the FDA. DOBI Medical Systems is seeking FDA approval for its noninvasive imaging system to be used as an adjunct to mammography to differentiate malignant from benign tumors by detecting angiogenesis development in the breast.

Module 2 contains information demonstrating compliance with a number of applicable design standards, including testing of ...

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Source: HighBeam Research, DOBI Medical Receives FDA Module Two Acceptance For...