Colorado MEDtech, Inc. Announces Update On FDA Status.Business/Health Editors BOULDER, Colo.--(BW HealthWire)--Sept. 17, 2001 Colorado MEDtech, Inc. (Nasdaq: CMED CMED Coordinated Medical Emergency Direction CMED Central Massachusetts Emergency Dispatch ), a Boulder, Colorado-based provider of advanced medical technology outsourcing (1) Contracting with outside consultants, software houses or service bureaus to perform systems analysis, programming and datacenter operations. Contrast with insourcing. See netsourcing, ASP, SSP and facilities management. services and medical imaging system components and accessories, announced today an update on its Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) regulatory status. The company had previously received a warning letter from FDA which stated that products subject to premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) could not be manufactured by the company until resolution of certain regulatory issues. In July, the company was re-inspected by FDA, and in August the company submitted a response to FDA. Since then, the company has had a number of discussions with the FDA regarding its regulatory status. Colorado MEDtech believes that as a result of its written response and these discussions, it has made progress in reaching resolution, although the final outcome and its timing are uncertain. We will continue to provide information on the status of this matter. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. The statements in this news release regarding the progress the company has made in resolving the FDA issues are forward-looking statements that represent management's beliefs and assumptions based on currently available information. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it cannot assure that these expectations will prove to be correct. Such statements involve risks and uncertainties, including the risk that the outcome of the FDA process will be unfavorable to the company and that expenses associated with compliance with the FDA Quality System Regulation may continue. Should these risks materialize (or the consequences of such a development worsen wors·en tr. & intr.v. wors·ened, wors·en·ing, wors·ens To make or become worse. worsen Verb to make or become worse worsening adjn ), or should the underlying assumptions prove incorrect, actual results could differ materially from those forecasted or expected. These factors are more fully described in the Company's documents filed from time to time with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update publicly or revise such statements whether as a result of new information, future events or otherwise. |
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