BioImagene Meets with FDA Officials to Discuss Pre-IDE Submission of the Diagnostic Product Version of Its PATHIAM(TM) Software
On Tuesday, July 5, 2005, BioImagene, Inc. met with members of the United States Food and Drug Administration’s Office of In Vitro Diagnostic Device Evaluation and Safety (FDA) 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 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 and Eli Lilly & Co. BioImagene is headquartered in San Mateo, California. For more information on BioImagene, visit the company’s web site at www.bioimagene.com .
