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Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System
Date:11/27/2007

will use the previous work in preparing the new single PMA filing. Once the new PMA application is submitted, a 180-day clock will begin for the FDA to review the application. The FDA may also require a panel of experts to review the findings in order to make a final recommendation."

According to FDA regulations, new technologies such as the Company's CT Laser Mammography system are subject to the PMA process. IDSI believes that it is prepared for the rigorous PMA process with well-documented, established and previously approved quality and manufacturing practices in place. The FDA has declared the current U.S. trial a non-significant risk (NSR) device study.

The Company is also governed by other international regulatory agencies. The CTLM system has completed registrations including the CE Mark, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.

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(R) 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(R)) 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.

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.

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