Confirma Receives ISO 13485:2003 and CE Marking Certifications for CADstream Breast MRI System.

KIRKLAND, Wash. -- Confirma, the market leader in computer-aided-detection (CAD) systems for MRI, today announced that it has achieved ISO 13485:2003 and Conformite Europeene (CE) Marking certifications for its CADstream system. The ISO Certification signifies Confirma's compliance with the quality management system standards developed by the International Organization for Standardization (ISO); the CE Mark allows Confirma to sell CADstream(TM), the standard in CAD for breast magnetic resonance imaging (MRI), in the European Union (EU).

"These certifications demonstrate that our focus remains on high quality, world-class performance," said Max Lyon, president and CEO, Confirma. "Additionally, we can now expand our business and offer CADstream in the European Union, where there is also a growing demand and market for CAD for breast MRI."

ISO is the international standard used to certify the safety and efficacy of products and processes, including design and development, manufacturing, delivery and service. Confirma's quality system and overall operations were assessed by BSI, which granted the ISO certificate and the CE Mark. To establish continued compliance with ISO 13485:2003 and CE Marking, BSI will periodically conduct routine surveillance audits of Confirma's business operations.

ISO and CE Marking Certifications

EC certificate No. CE 88939 was issued by BSI and applies to CADstream which complies with the requirements of Council Directives 93/42/EEC, Annex VI, section 3.2. CADstream is now available to the European market. Many of the pioneering physicians in breast MRI are in the EU, and CADstream's availability there is an important step in further developing the product and expanding Confirma's market opportunities. CADstream was introduced in the United States in 2002 and, since that time, more than 150 CADstream systems have been sold in the US, making CADstream the industry standard in CAD systems for reading breast MRI studies.

About Confirma, Inc.

Confirma, Inc. develops and markets computer-aided-detection (CAD) systems for medical imaging applications. Confirma's product, CADstream, is the standard in CAD for MRI. CADstream provides higher quality imaging studies, lower costs for radiology practices and improved communication tools for physicians and patients. In its initial application, CADstream is being used to assist in the analysis of breast MRI; the company plans future applications in other medical imaging studies. For more information, visit www.confirma.com or call 877-976-1226.