Imaging Diagnostic Systems Breast Scanner Performance Upgrade Program Nearing Completion

Main Category: MRI / PET / Ultrasound
Also Included In: Breast Cancer;  Women's Health / Gynecology
Article Date: 11 May 2007 - 0:00 PDT

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Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) a pioneer in laser optical breast imaging systems, announced today that the majority of international CTLM(R) systems have been upgraded to the 4.1 Performance Package level, which includes several significant enhancements.

According to Tim Hansen, Imaging Diagnostic Systems' Chief Executive Officer, "When we launched our US FDA Premarket Approval data collection study, we announced that many improvements had been made to the CTLM system since the prior study in 2001. We wanted our global users to share in these improvements as well; recent shipments from our factory have routinely included the 4.1 Package. Our plan has always been to upgrade the installed CTLM base as well." Continued Hansen, "We are now nearing completion of that field upgrade program, done entirely at IMDS expense, to ensure continued customer satisfaction and excellent CTLM system performance. The remaining upgrade sites include China and sites pending final installation. This upgrade to the highest performance level has been a major accomplishment for our organization and a source of great satisfaction for our users."

The 4.1 Package enhancements include: new scan control software to reduce scan time from 12 to 9 minutes, increasing patient throughput by 25% while adding to patient comfort and reducing patient movement artifacts; CTLM self- diagnostic background software to monitor for potential faults and to log quality-assurance data for service purposes; improved software to simplify daily calibration routines; customer-driven changes to the image presentation displays to allow faster, more flexible viewing; and, specifically for the international installed base, operator interface software that enables simplified translation into non-English languages.

"Our users are very pleased with the enhancements and with the support they have received from IMDS, and our distributors are similarly pleased that we have provided the resources to complete the upgrades and training. Some users, who had worried about technologically 'falling behind' the US PMA sites, are now quite content. We want them to be thrilled not only with the new optical molecular imaging capabilities but also with our support of their work," added Tim Hansen. "We are making steady progress in our US PMA study with these newer systems, and now we have a solid updated installed global base."

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.

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(R)) 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: http://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.

Imaging Diagnostic Systems
http://www.imds.com