A Diagnostics & Imaging Week
BioImagene (San Mateo, California) said it met earlier this month with members of the FDA Office of In Vitro Diagnostic Device Evaluation and Safety to discuss the regulatory pathway for commercialization of its Pathiam software product.
BioImagene said it is planning to introduce a diagnostic product version of its Pathiam software and that, based on its discussions with the FDA, it expects to proceed with the preparation of a pre-investigative device exemption submission to FDA for the diagnostic version of the 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 President and CEO Mohan Uttarwar.
BioImagene provides bio-image analysis products built on its iHarness technology platform. Through its recent acquisition of Scimagix and its Scientific Information Management System (SIMS) product, BioImagene has expanded its product offerings of image informatics solutions.