DOBI MEDICAL SYSTEMS SUBMITS THIRD MODULE IN FDA APPLICATION PROCESS FOR ITS NON-INVASIVE BREAST IMAGING SYSTEM
Mahwah, New Jersey, August, 2001. DOBI Medical Systems, LLC, announced today that it has submitted Module 3 of its Pre-Market Approval (PMA) application for its Dynamic Optical Breast Imaging System, called ComfortScan, to the U.S. Food and Drug Administration (FDA). Submission of this module will further DOBI Medical Systems' goal in seeking FDA approval for its non-invasive imaging system to be used as an adjunct to mammography to differentiate malignant from benign tumors in the breast by identifying angiogenesis.
DOBI Medical Systems is utilizing the FDA's modular submission approach, which divides the traditional PMA application into five 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 received submission of the second of the five modules required for the Companyâs PMA.
Module 3 contains detailed information on Predicted Reliability and Durability, Hazards Analysis, Firmware and Software. In announcing the submission of Module 3 to the FDA, Phillip C. Thomas, President and Chief Executive Officer of DOBI Medical Systems said, "We are very happy with the results of the reliability and durability testing reported in Module 3, which demonstrated that after 15,000 cycles ComfortScanú continued to perform within specifications.
John D. Gardner, Vice President, Technology further explained, ãOur Hazards Analysis demonstrates that DOBI Medical has considered the impact of potential failures caused by human factors, software, mechanical and electrical systems. The identification and mitigation of these potential hazards is a major milestone in the design and manufacturing of medical devices such as ours. In addition, we have extensively tested and reviewed firmware and software to demonstrate safe and reliable operation."
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