FORT LAUDERDALE, Fla., Aug. 8 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., announced that a CT Laser Mammography (CTLM(R)) system has been shipped to Colombia for installation in a prestigious private mammography center in Bogota. The center specializes in breast screening as well as diagnostic exams using conventional mammography and ultrasound techniques.
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CTLM imaging will be conducted under the direction of Dr. Bernardo Sanchez and his staff.
“I am looking forward to working with the CTLM system,” stated Dr. Sanchez. “It will fit in very well with the modalities and the types of cases that we treat, particularly women with dense breasts and breast implants. We would also like to use CTLM technology to evaluate patients who are undergoing treatment for breast cancer.”
The CTLM system is being installed to generate local physician and patient interest in the new noninvasive laser imaging technology. IDSI has been developing the South American market through a reference system installed in Argentina and through participation in imaging congresses and symposia.
“We are pleased to have placed the first CTLM system in Colombia and expanded our South American position,” stated Deborah O’Brien, IDSI Senior Vice President. “Through the efforts of Dr. Sanchez in Colombia and progress in Argentina, we will increase the commercial and clinical exposure of CT Laser Mammography.”
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 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 limited by United States Federal Law to investigational use only in the United States. 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: www.imds.com for additional information.
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.
Investor Relations: Rick Lutz 404-261-1196 lcgroup@mindspring.com
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CONTACT: Rick Lutz of Imaging Diagnostic Systems, Inc., +1-404-261-1196,or lcgroup@mindspring.com
Web site: http://www.imds.com//