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I know that there a lot of you out there looking for information on IMDS. Here is exactly where they stand at this time. Please repond to this and I will get you any information you need. More info available at www.hawkegroup.com under current clients section On Thursday, March 19, 1998, the FDA approved Imaging Diagnostic Systems, Inc. (IDSI) to expand human studies to three additional clinical sites. Additionally, the Company also received FDA approval to resume in-house calibration studies. Imaging Diagnostic Systems, Inc. has developed the first patented laser- based breast imaging system that utilizes state of the art laser technology and sophisticated computed algorithms that create contiguous cross-sectional slice images of the breast. This procedure known as the CTLMT does not require breast compression or x-rays. Linda Grable, president, feels the March 19 announcement "not only shows the FDA's willingness to assist IDSI in bringing the CTLMT device to market, but also clearly demonstrates their confidence in both the company and it's technology." The Development Team is finalizing on-site preparation for in-vivo (human) clinical studies. The Clinical Group is establishing Institutional Review Boards in three prominent university centers. The Company expects initial foreign deliveries of CTLMT devices in late spring or early summer. "If the clinical trials go as smoothly as we anticipate, we should have pre-marketing approval by the end of 1998, which will enable us to sell domestically," stated Richard Grable, CEO and founder. These recent developments continue the accelerated positive track IDSI has been on since the RSNA (Radiological Society of North America) meeting in late 1997. That meeting established "Medical Optical Imaging" as the diagnostic tool of the 21st century and put Imaging Diagnostics on the forefront of this cutting edge technology which is becoming widely accepted due to the expanding capabilities of lasers and computers. Three dramatic events during this meeting positioned IDSI as the fields recognized pioneer and leader. A scientific presentation given by Dr. Britton Chance (University of Pennsylvania) and Dr. Bruce Rosen (Harvard Medical) titled "Optical Imaging at its threshold." Imaging Diagnostics was the only vendor present with known in-vivo studies. The quantum advancement in IDSI's image quality from continuous wave to enhanced time-resolved imaging was clearly demonstrated. Imaging Diagnostics "In-Vivo" images clearly identified several known abnormalities. | ||||||||||||||
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