Healthcare Industry News: computed tomography
News Release - May 1, 2006
Imaging Diagnostic Systems' CT Laser Breast Imaging Scanner Enters US FDA Clinical TrialsFORT LAUDERDALE, Fla., May 1 (HSMN NewsFeed) -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS ) announced today that clinical trials of the CT Laser Mammography (CTLM®) system have commenced at a number of US university medical centers. IDSI will collect clinical data through a non- significant risk (NSR) device study.
"As previously reported, we will be scanning patients using the latest version of the CTLM system," commented Deborah O'Brien, Senior Vice President of Imaging Diagnostic Systems. "Following data collection and analysis, we intend to submit a Premarket Approval application to the FDA for the use of CTLM as an imaging adjunct to conventional diagnostic mammography. CTLM has the potential to fill an important role in improving the accuracy of current breast cancer detection methods and in improving patient management. We are partnering with prestigious institutions, using an experienced clinical study management firm, working with leading regulatory consultants, and using our best efforts to ensure successful clinical trials."
"We are also moving forward in our global commercialization efforts. We held our first International CTLM Users Meeting in April. Many of our international users have gained useful experience and collectively have scanned over 7,000 breasts. IDSI recently participated in the European Congress of Radiology, where several of our luminary partners presented clinical studies," O'Brien added.
The Company will continue to provide periodic updates of its progress on current initiatives, including the US PMA process, by way of shareholder letters, press releases, and other public filings. The locations of the clinical trials will not be disclosed so that the study members may participate without publicity or distraction.
Imaging Diagnostic Systems is seeking FDA Premarket Approval (PMA) for its computed tomography Laser Mammography (CTLM®) system to be used as an adjunct to mammography. The Company's PMA application will be submitted in its entirety at the completion of the data collection and review process. 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 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. 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.
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. We expressly disclaim any intent or obligation to update any forward-looking statements.
Source: Imaging Diagnostic Systems
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