Imaging Diagnostic Systems' CT Laser Mammography Technology Featured at Polish Congress of Oncology
Posted on: Monday, 6 November 2006, 09:01 CST
FORT LAUDERDALE, Fla., Nov. 6 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (BULLETIN BOARD: IMDS) , announced that CT Laser Mammography (CTLM(R)) clinical cases were featured at the 2nd International Polish Congress of Oncology, October 25-28, in Poznan, Poland.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040412/IMDSLOGO)
The clinical cases were presented at the booth of IDSI's Polish distributor, EDOMED, who was a major sponsor of the Congress.
"Our clinical cases and presentations created a lot of interest from breast imaging and oncology therapy specialists," stated Deborah O'Brien, IDSI Senior Vice President. "The increased exposure we receive in Poland from exhibitions and from our placements in leading centers has generated interest in this market for CTLM. With three systems in leading oncology centers and more pending, Poland represents an important market for CT laser breast imaging technology."
Organized by various Polish national societies, the Congress attracted 1,900 attendees, 200 of which were international members.
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.
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
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20040412/IMDSLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.com
Imaging Diagnostic Systems, Inc.
CONTACT: Investor Relations, Rick Lutz for Imaging Diagnostic Systems,Inc., +1-404-261-1196, or lcgroup@mindspring.com
Web site: http://www.imds.com/
Source: PRNewswire-FirstCall
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