Healthcare Industry News: computed tomography
News Release - November 15, 2007
New Optical Breast Cancer Imaging Technology Garners Cover Story in National Radiology MagazineFORT LAUDERDALE, Fla., Nov. 15 (HSMN NewsFeed) -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS ) a pioneer in laser optical breast cancer imaging systems, announced that its CT Laser Mammography (CTLM®) system, designed as an adjunct to x-ray systems to detect breast cancer, and its future clinical applications were featured in a cover story in the September 17, 2007 issue of RT Image magazine. This major article was contributed by Eric Milne, MD, FRCR, FRCP, IMDS Director of Clinical Research.
The article, "CT Laser Mammography Functional Optical Imaging of Breast Cancer," can be viewed on the RT Image website at: www.rt-image.com.
CTLM may solve some of the clinical problems associated with current breast cancer detection methods. Professor Milne explains, "The incidence of breast cancer is growing steadily throughout the world. There is an urgent need for a simple, easily installed, inexpensive - but reliable - method of detecting breast cancer at an early stage that does not employ ionizing radiation or require the injection of contrast media, and has greater sensitivity and specificity than current mammographic techniques."
The CTLM procedure is not yet FDA approved, but it was featured in RT Image as one of the newest breast imaging technologies; its possible future applications were the focus of the article. RT Image, an award-winning magazine, has been published for 20 years and is the only national, weekly magazine for radiology professionals.
About Imaging Diagnostic Systems, Inc.
Imaging Diagnostic Systems, Inc. has developed a revolutionary new imaging device to aid in the detection and management of breast cancer. The CTLM® system is a breast imaging system that utilizes patented continuous wave laser technology and computer algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to ionizing radiation or painful breast compression. CT Laser Mammography (CTLM®) is designed to be used in conjunction with mammography. It reveals information about blood distribution in the breast and may visualize the process of angiogenesis, which usually accompanies tumor growth.
Imaging Diagnostic Systems is currently collecting data from clinical sites for the future filing of an FDA Premarket Approval (PMA) for the computed tomography Laser Mammography (CTLM®) system to be used as an adjunct to mammography. The FDA has determined that the Company's clinical study is a non-significant risk (NSR) investigational device study under 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812). The CTLM system is limited by United States Federal Law to investigational use only in the United States. The CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
For more information, visit our website: www.imds.com
As contemplated by 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, or projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates or predictions of future results or events and there can be no assurance that actual results or events will not materially differ from expectations. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company's filings with the Securities and Exchange Commission. We expressly disclaim any intent or obligation to update any forward-looking statements.
Source: Imaging Diagnostic Systems
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