VIDA Diagnostics Earns ISO 13485 and CE Certifications
Published: Sep 19, 2011
CORALVILLE, Iowa, Sept. 19, 2011 /PRNewswire/ -- VIDA Diagnostics, a leading developer of quantitative pulmonary imaging software, announced today that the company has achieved International Organization for Standardization (ISO 13485) certification and CE certification for its flagship product, Apollo®. The CE certification permits VIDA to sell Apollo for clinical use in the European Economic Area (EEA) and Switzerland. Apollo currently has FDA 510(k) approval for clinical use in the U.S.
Apollo is VIDA's recently released, pulmonary image analysis solution designed to assess pulmonary disease objectively and repeatedly with unprecedented speed and accuracy. Used for the early detection, evaluation and aiding of treatment of pulmonary disease including COPD, emphysema, lung cancer, and asthma; VIDA's analysis methodology has been successfully tested in multiple academic and clinical trials.
"Receiving these certifications are significant milestones for VIDA Diagnostics in establishing high quality standards and generating a solid platform for commercialization in the worldwide market," stated Susan A. Wood, Ph.D., VIDA Diagnostics' President and Chief Executive Officer. "We are excited to expand the reach of VIDA solutions."
VIDA Diagnostics will be attending the European Respiratory Society 2011 Congress in Amsterdam, Netherlands, September 25-28, 2011.
About VIDA Diagnostics
VIDA Diagnostics is a leader in clinically-validated quantitative pulmonary analysis software for the early detection, evaluation and treatment of pulmonary disease including COPD, emphysema, lung cancer, and asthma. FDA approved and CE certified, VIDA's analysis methodology has been successfully tested in multiple academic, pulmonary device, and pharmaceutical clinical trials.
SOURCE VIDA Diagnostics