Imaging Diagnostic Systems' 'Painless Mammogram' eliminates drawbacks of conventional screening.
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Dec. 14, 1995--The Chief Executive Officer, President and General Counsel of Imaging Diagnostic Systems Inc. (OTC OTC
See over-the-counter market (OTC). EBB:IMDS IMDS International Material Data System (automotive)
IMDS Integrated Maintenance Data System
IMDS Image Data Stream (Format)
IMDS Integrated Mechanical Diagnostics System ) met with the FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. on Dec. 12 and submitted a pre IDE application and expects to submit in 7 to 10 days a formal Investigational Device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and application.
Imaging Diagnostic Systems will be the modality of choice with its revolutionary CT Laser Mammography. The CTLM CTLM Imaging Computed tomography laser mammography A diagnostic technique using lasers to produce a 3-D cross-sectional image of the breast without x-rays. See Mammography. (tm) uses high-speed laser technology with sophisticated algorithms to produce images while eliminating the drawbacks of radiation and discomfort from breast compression for the life-saving diagnostic procedure.
With comparative studies commencing, IDS is preparing to meet the demands of the domestic and international market for its new device, which generated global interest at the recent RSNA RSNA Radiological Society of North America, Inc.
RSNA Robust Security Network Association conference, including several prestigious medical institutions in the United States.
The CTLM(tm) was recently featured on the Donahue Show and on ABC News, CBS (Cell Broadcast Service) See cell broadcast. National News, WPIX-TV and articles in The Wall Street Journal and Associated Press. IDS has also received industry accolades for their advancement in laser technology for improved Medical Optical Imaging in numerous trade publications including, The Gray Sheet, Diagnostic Imaging and Applied Radiology. The CTLM(tm) is being referred to by the consumer as the "Painless Mammogram."
"Women have been waiting a long time for something less painful and more dignified to come along, and with CTLM(tm) we will reach a large sector of the female population that refuses to be subjected to traditional methods of mammography," said Richard Grable, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. and inventor of the CTLM. "We know we have an exceptional product that is years ahead of even the largest companies," he said.
"Until we have the green light from the FDA, we will pursue clinical sites in the U.S. and sales in the foreign markets," said Linda Grable, president of IDS. One of Europe's largest distributors of medical equipment, Medical Development East, is negotiating delivery of the CTLM(tm) for placement at the Moscow Research in Russia in July 1996. Current sales to the Asian market for delivery in 1996 is approximately $1.5 million.
Imaging Diagnostic Systems Inc. has a proprietary state-of-the-art breast imaging device, CTLM(tm) which requires no breast compression, uses no x-rays -- producing detailed cross-sectional images of the tissue.
CONTACT: International Buying Power Corp., Boca Raton, Fla.
407/392-3404, fax 407/392-4775