Imaging Diagnostic Systems Selects M Squared Associates To Monitor Clinical Trials

FORT LAUDERDALE, Fla., Jan. 3 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., announced today that M Squared Associates of Washington, DC, has been selected by IDSI to audit and monitor the company’s clinical trials.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040412/IMDSLOGO )

“We are very pleased to have M Squared as our clinical trial monitor,” stated Deborah O’Brien, Senior Vice President, IDSI. “It is highly important to us that we have exacting standards for following protocol and ensuring that the data is properly collected. With everything that M Squared has to offer, we look forward to working with them.”

M Squared Associates will provide both expertise in clinical study management as well as experience with the FDA. The company’s senior staff includes past executive managers from both Fortune 500 and early stage medical device companies, as well as past managers from the FDA Center for Devices and Radiological Health.

“We’re very proud to be part of the team for the CTLM clinical study,” said Marie Marlow, President and CEO of M Squared Associates. “We consider it a compliment when a company such as Imaging Diagnostic Systems chooses M Squared Associates as its contract research organization (CRO) partner. The CTLM system could benefit thousands of women with a potential diagnosis of breast cancer, so it’s important to me both personally and professionally that this clinical study is well-run and supports a quick FDA approval.”

M Squared Associates was founded in 2001 to specifically serve the clinical and regulatory needs of the medical device industry. The company specializes in bringing medical devices to market.

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 cross-sectional images of the breast. It is a non-invasive, painless examination that does not expose the patient to radiation or require breast compression. Imaging Diagnostic Systems has received CE Marking, CMDCAS (Canada), Canadian License, China SFDA approval, UL listing, ISO 9001:2000-13488 certification and FDA export certification for its CT Laser Breast Imaging system. The Company is seeking PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for its CTLM(R) system to be used as an adjunct to mammography.

Please visit Imaging Diagnostic Systems’ website at: http://www.imds.com for additional information.

In conjunction with 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 projected plans, performances and developments, as well as other statements relating to future operations. All such forward-looking statements are necessarily only estimates of future results and there can be no assurance that actual results will not materially differ from expectation. Further information on potential factors that could affect Imaging Diagnostic Systems, Inc., is included in the Company’s filing with the Securities Exchange Commission.

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.orgPRN Photo Desk, photodesk@prnewswire.comImaging Diagnostic Systems, Inc.

CONTACT: Rick Lutz, Imaging Diagnostic Systems, +1-404-261-1196, orlcgroup@mindspring.com

MORE ON THIS TOPIC