FORT LAUDERDALE, Fla., April 25 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., held the 1st International CTLM Users Meeting, a forum for physicians throughout the world who work with the CT Laser Mammography system. Hosted by Alexander Poellinger, MD, a principal CTLM investigator at Charite Hospital in Berlin, Germany, the April 22 - 23 meeting allowed users to share their clinical and scientific experiences with the innovative CTLM(R) technology, to discuss patient study results, and to exchange ideas for future radiologic and oncologic applications of this exciting new technology.
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Professor Bernd Hamm, Director of the Department of Radiology at the Charite Hospital, stated, "Our department offers a wide variety of state-of- the-art diagnostic procedures, including digital mammography, sonography, breast MRI, and vacuum-assisted breast biopsy. As one of the largest university hospitals worldwide, we have been working on different innovative imaging technologies including impedance scanning, contrast-enhanced digital mammography and laser optical mammography. CTLM, as a new diagnostic tool, yields the possibility of being added to this multidisciplinary approach. We are very proud to have hosted the first CTLM users' meeting in Berlin."
Physicians at the 1st International Meeting represented some of the world's leading research hospitals, including Charite Hospital, Berlin, Germany; Catholic University, Rome, Italy; Gazi University, Ankara, Turkey; Charles University, Prague, Czech Republic; Maria Sklodowska-Curie Memorial Cancer Center, Gliwice, Poland; and the Medical University of Vienna, Vienna, Austria. Works from other sites were also presented.
"We have developed a large body of work, which made it imperative to convene our 1st International CTLM Users Meeting. The meeting allowed us to gather and document significant clinical observations and data developed by the CTLM user physicians. These physicians have been routinely providing us with valuable information; it was important to have them share experiences with peers because this technology is so new and unique. We appreciate the input from such experienced users of the CTLM system, who together have performed over 7000 clinical scans," stated Deborah O'Brien, Senior Vice President, Imaging Diagnostic Systems.
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Mammography (CTLM(R)) system to be used as an adjunct to mammography. The Company's PMA application will be submitted in its entirety at the completion of the data collection and review process. The FDA has determined that the Company's clinical investigation is a non-significant risk (NSR) investigational device study because it does not meet the definition of a significant risk (SR) device under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM(R) system is the first patented breast imaging system that utilizes state-of-the-art laser technology and patented algorithms to create 3-D cross-sectional images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. IDSI has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000- 13488 certification and FDA export certification for its CT Laser Mammography system.
Please visit Imaging Diagnostic Systems' website at: http://www.imds.com for additional information.
In conjunction with the provisions of the Safe Harbor section of the Private Securities Litigation Reform Act of 1995, this news release may contain forward-looking statements pertaining to future anticipated projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company's filing with the Securities Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.
Investor Relations: Rick Lutz 404-261-1196 lcgroup@mindspring.com
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Web site: http://www.imds.com/
