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NEWS & PRESS RELEASE ARCHIVES
Wednesday, December 31, 1969 :: Imaging Diagnostic Systems New Laser Breast Imaging Scanner Introduced in Malaysia Wednesday, December 31, 1969 :: CT Laser Mammography Technology Featured at Largest EU Radiology Congress
Imaging Diagnostic Systems New Laser Breast Imaging Scanner Introduced in Malaysia
Tuesday September 4, 9:30 am ET
FORT LAUDERDALE, Fla., Sept. 4 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS - News) a pioneer in laser optical breast cancer imaging systems, has shipped a CT Laser Mammography (CTLM®) system to the Universiti Putra Malaysia (UPM) in Kuala Lumpur, Malaysia, the first such scanner in the country.
The CTLM system will be installed at UPM's academic facility within the jurisdiction of the Ministry of Education and will be evaluated by specialists from UPM in conjunction with specialists from Serdang Hospital in Kuala Lumpur.
An IMDS spokesperson said, "We are pleased to add Malaysia to those areas in Asia where CTLM is being considered as a possible solution for improving the diagnosis and management of breast cancer cases. UPM is very forward- looking and, we believe, focused on improving women's health services through advanced technologies."
The CTLM system is expected to be in service by Oct 1st.
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.
Investor Relations:
Rick Lutz
(404) 261-1196
lcgroup@mindspring.com
Media Contact:
Elizabeth Williams
(954) 581-9800
CT Laser Mammography Technology Featured at Largest EU Radiology Congress
Fort Lauderdale, Florida, March 6, 2007—Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast imaging systems, will exhibit new CT Laser Mammography (CTLM) clinical cases at the annual European Congress of Radiology (ECR 2007), March 9-13, in Vienna, Austria. IDSI will be located at Expo A #115.
“We are pleased to present many impressive clinical case posters from some of our clinical sites, commented Deborah O’Brien, IDSI’s Senior Vice President. “The posters compare CTLM with conventional mammography, ultrasound, and MR. One of our featured posters, a work-in-progress from Catholic University in Rome, Italy, compares CTLM to MR for detecting remaining angiogenesis after neoadjuvant therapy. The MR studies were negative after treatment, but CTLM remained positive. Biopsy confirmed that cancer was still present, suggesting that CTLM may be more sensitive than MR for treatment monitoring. These results reveal exciting possible future applications for CTLM technology.”
One of the largest medical meetings in Europe and the second-largest radiology meeting in the world, ECR 2007 will attract approximately 16,000 participants.
The CTLM system is a new continuous wave laser breast imaging system that utilizes state-of-the-art technology and patented algorithms to create 3-D images of the breast. The procedure is non-invasive, painless, and does not expose the patient to radiation or require breast compression. In the United States, Imaging Diagnostic Systems is seeking 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 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 system is limited by United States Federal Law to investigational use only in the United States. The Imaging Diagnostic Systems CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
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
