BioImagene Meets with FDA Officials to Discuss Pre-IDE Submission of the Diagnostic Product Version of Its PATHIAM(TM) Software.SAN MATEO San Mateo (săn mətā`ō), city (1990 pop. 85,486), San Mateo co., W Calif., on San Francisco Bay; inc. 1894. It is a commercial and retail center with some high-technology manufacturing. San Mateo, Spanish for St. , Calif. -- On Tuesday, July 5, 2005, BioImagene, Inc. met with members of the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. Food and Drug Administration's Office of In Vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. Diagnostic Device Evaluation and Safety (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. ) to discuss the regulatory pathway for commercialization of BioImagene's PATHIAM software product. BioImagene is planning to introduce a diagnostic product version of its PATHIAM software; therefore, necessary regulatory aspects of such a product were discussed and clarified for senior executives of BioImagene in this meeting. BioImagene believes that the discussions with FDA were very useful and informative for both parties. As a result, BioImagene expects to proceed with the preparation of a pre-IDE submission to FDA for the diagnostic product version of its PATHIAM software. "While BioImagene takes great pride in bringing innovative technology solutions for the scientific research community for betterment of patient care, it is equally committed to taking necessary steps to ensure regulatory compliance to facilitate offering of a diagnostic version of PATHIAM software product. The meeting with FDA is a major step in that direction," said Mohan Uttarwar, President and 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. of BioImagene. About BioImagene BioImagene provides sophisticated bio-image analysis products built on iHARNESS(TM), its proprietary technology platform. BioImagene's products allow pathologists and researchers to analyze images with far greater speed and consistency. The data management systems and web-based nature of BioImagene's technology facilitate communication and collaboration, improving the standard of pathology research and increasing the speed of drug discovery. Its scalable digital image analysis and management solutions for research use have been embraced by histopathologists, researchers, and industry alike. Through its recent acquisition of Scimagix, Inc. and its marquee product SIMS (Scientific Information Management System), BioImagene has expanded its product offerings of image informatics solutions. The company serves most of the top 15 pharmaceutical companies, including Pfizer Global R&D, Hoffmann La Roche La Roche may refer to:
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