FDA ACCEPTS THIRD MODULE FOR DOBI MEDICAL SYSTEMS NON-INVASIVE BREAST IMAGING SYSTEM
Mahwah, New Jersey, November 19, 2001. DOBI Medical Systems, LLC, announced today that the U.S. Food and Drug Administration (FDA) has accepted the third module of its Pre-Market Approval (PMA) application for its Dynamic Optical Breast Imaging System, called ComfortScan. This module, which was submitted in August, is part of the Company's five-module submission plan previously approved by the FDA. DOBI Medical Systems is seeking FDA approval for its non-invasive imaging system to be used as an adjunct to mammography to differentiate malignant from benign tumors by detecting angiogenesis in the breast.
DOBI Medical Systems is utilizing the FDA's modular submission approach,which divides the traditional PMA application into modules. This system allows progressive review and acceptance of each modular portion of the total data required, thus facilitating the overall approval process. The FDA has previously accepted the first and second of the five modules required for the Company's PMA.
Module 3 contains detailed information on Predicted Reliability and Durability, Hazards Analysis, Firmware and Software. In announcing the acceptance of Module 3 by the FDA, Phillip C. Thomas, President and Chief Executive Officer of DOBI Medical Systems said, "We are pleased that the FDA approval process has moved along expeditiously and continue to be optimistic regarding the progress we are making on our angiogenesis based breast imaging system.
John D. Gardner, Vice President, Technology added, Module 3 provided our detailed hazards analysis which demonstrated that DOBI Medical Systems has considered and mitigated the impact of potential failures caused by human factors, software, mechanical and electrical systems.
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