Imaging Diagnostic Systems to Exhibit Laser Breast Imaging Device at Major Middle East Health Conference
FORT LAUDERDALE, Fla., Jan. 23 -- Imaging Diagnostic Systems, Inc., (BULLETIN BOARD: IMDS) will highlight its patented CT Laser Mammography (CTLM(R)) system at Arab Health 2007, January 29-February 1 in Dubai, United Arab Emirates. IDSI will be located in the U.S. Pavilion.
The CTLM(R) system is an innovative continuous wave laser breast imaging system that utilizes state-of-the-art technology and patented algorithms to create 3-D images of the breast. There are two operating clinical CTLM(R) systems in Dubai; over 8,000 breast studies have been performed globally using the system. The procedure is non-invasive, painless, and does not expose the patient to radiation or require breast compression.
Arab Health is the largest healthcare exhibition in the Middle East and one of the largest healthcare events in the world. Over 33,000 visitors are expected to attend the exhibition and its multi-track series of conferences.
In the United States, Imaging Diagnostic Systems is seeking 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 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 limited by United States Federal Law to investigational use only in the United States. The Imaging Diagnostic Systems CTLM system has received other registrations including CE, CMDCAS Canadian License, China SFDA, UL, ISO 9001:2000, ISO 13485:2003 and FDA export certification.
Web site: http://www.imds.com/
