FORT LAUDERDALE, Fla., May 23 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc. announced that the CT Laser Mammography (CTLM(R)) system was recently featured in two European publications.
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An article written by the Secretary General of the European Society of Breast Imaging (EUSOBI), Professor Thomas Helbich, MD, of the Medical University of Vienna, appeared in a special edition of the European Congress of Radiology newsletter, Newstyle. The article discussed the topics of the EUSOBI annual scientific meeting, Breast Imaging Update, as well as topics at ECR. Professor Helbich discussed the principles of CTLM technology and research conducted at the Medical University of Vienna with the CTLM system, as well as future applications. “Through molecular imaging with laser, an improved diagnosis of breast tumours has become possible -- and without the slightest exposure to radiation,” Helbich stated. The complete article can be viewed by visiting the ECR website: http://www.ecr.org/media/download/ecr2006_newstyle_special.pdf .
European Hospital’s April/May 2006 issue featured an article, “CTLM Seeing through the dense breast” by Professor Eric Milne, MD, IDSI Director of Clinical Research. The article can be viewed by visiting the European Hospital website: http://www.europeanhospital.com/en/issues/articleview.php?id=45 .
“Breast imaging continues to attract new solutions such as digital mammography, MRI guidance, and CTLM. We are pleased to see the clinical and commercial interest in our revolutionary new approach to breast imaging,” stated Tim Hansen, Chief Executive Officer, IDSI.
IDSI continues to pursue a global commercialization initiative built upon the clinical and research efforts of CTLM users worldwide, including Europe, China and the Middle East.
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its Computed Tomography Laser 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 images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. The CTLM system is an investigational device and is not available in the United States. It is limited by United States Federal Law to investigational use. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000, ISO 13485:2003 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 and 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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CONTACT: Rick Lutz, +1-404-261-1196, or lcgroup@mindspring.com, forImaging Diagnostic Systems