FORT LAUDERDALE, Fla., June 28 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., announced today that Jose Cisneros, MD, PhD, IDSI Assistant Director of Clinical Research, will be a presenter at the 1st Symposium on Breast Imaging on June 28 in Buenos Aires, Argentina.
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The symposium will be held at Maimonides University and is sponsored by the Institute of Multiple Automatic Analyses (IAMA). The Institute features a Women’s Health department, which recently began patient studies with the CT Laser Mammography system (CTLM(R)). It is the first CTLM system operating in the country.
Entitled “The Current State of Breast Imaging Modalities,” the symposium is designed to inform physicians in the region on updates and developments in breast imaging. Dr. Cisneros will give two presentations: “Physical and Technological Fundamentals of Breast Imaging Modalities,” and “Conclusions on the Current Workflow of Breast Imaging Diagnosis.”
“With the symposium’s emphasis on multiple modalities, the new CTLM technology will be introduced as a tool to be used in conjunction with mammography to diagnose breast cancer,” stated Dr. Cisneros. “My presentations will explain how and when CTLM studies may be needed to provide additional information on difficult cases such as dense breast studies.”
The Company’s CTLM system recently entered US clinical trials to gather data for submission of a PMA application.
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: http://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: Investor Relations, Rick Lutz, +1-404-261-1196, orlcgroup@mindspring.com, for Imaging Diagnostic Systems, Inc.
Web site: http://www.imds.com/
