Direct Medical Systems, LLC Submits FDA Application For Their M3000 Mammography System

SAN RAMON, Calif., Nov. 29 /PRNewswire/ -- Direct Medical Systems, LLC (DMS) of San Ramon has announced the submission of an application to the Food and Drug Administration (FDA) for clearance to market their M3000 Mammography system. This is one of several applications that DMS plans to submit over the next few months. DMS imports medical diagnostic equipment such as magnetic resonance imaging systems (MRI), computed axial tomography scanners (CT) and ultrasound systems from a joint venture between a manufacturing company in China and the government of The People’s Republic of China.

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Upon receiving FDA clearance, DMS will market their products through one of the largest distributors and service organizations in the United States. DMS plans to offer their products through this distributor in the US and Internationally through a network of reputable distributors who will provide these systems at lower prices while maintaining the quality of service and support the industry has come to expect.

“We continue to add international distributors to our growing list throughout the world. We also offer product conception to design and then manufacture the product at our facilities in China,” said Mark Falkowski, President & CEO of Direct Medical Systems.

Direct Medical Systems currently has contracts with several US and International companies to manufacture products at their factories in China. These products are all in diagnostic imaging and provide our clients with high quality manufacturing at lower costs. DMS’ manufacturing division continues to be the fastest growing division in the company.

The total world market for diagnostic imaging equipment is estimated to be over $16 billion in 2005 with the United States accounting for approximately 50% of the total market. DMS through its distributor network plans to become a major competitor in this market by offering customers low cost alternatives to those offered by traditional suppliers of this equipment.

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NOTE: Certain of the statements contained herein may be statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words ‘may, will, should, expects, plans, intends, anticipates, believes, estimates, predicts, potential, or continue’ and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to, without limitation, (i) general economic conditions, including in particular economic conditions in the Direct Medical Systems core business and core markets, (ii) performance of financial markets, including emerging markets, (iii) the frequency and severity of insured loss events, (iv) mortality and morbidity levels and trends, (v) persistency levels, (vi) the extent of credit defaults (vii) interest rate levels, (viii) currency exchange rates including the China-Euro-U.S. Dollar exchange rate, (ix) changing levels of competition, (x) changes in laws and regulations, including monetary convergence and the European Monetary Union, (xi) changes in the policies of central banks and/or foreign governments, (xii) the impact of acquisitions, including related integration issues, (xiii) reorganization measures and (xiv) general competitive factors, in each case on a local, regional, national and/or global basis. Many of these factors may be more likely to occur, or more pronounced, as a result of terrorist activities and their consequences. The company assumes no obligation to update any forward-looking information contained herein.

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CONTACT: Mark Falkowski of DMS, +1-925-683-4842

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