|
| [January 25, 2006] |
 |
Aurora Imaging Technology, Inc. Achieves ISO 13485:2003, CMDCAS and CE Marking Certifications for the Aurora(R) 1.5T Dedicated Breast MRI System
NORTH ANDOVER, Mass. --(Business Wire)-- Jan. 25, 2006 -- Aurora Imaging Technology, Inc., manufacturers of the first and only FDA cleared MRI system designed specifically for breast imaging, today announced that it has achieved ISO 13485:2003, CMDCAS and Conformite Europeene (CE) Marking certifications for its Aurora(R) 1.5T Dedicated Breast MRI System with Bilateral RODEO(R) (Rotating Delivery of Excitation Off-Resonance). The ISO Certification signifies Aurora Imaging Technology's compliance with the quality management system standards developed by the International Organization for Standardization (ISO). The CE Mark allows Aurora Imaging Technology, Inc. to sell the Aurora(R) 1.5T Dedicated Breast MRI system in the European Economic Area (EEA) while CMDCAS allows for sales to Canada.
"These certifications demonstrate Aurora's total commitment to high quality control standards and providing the international market with the latest advancements in breast cancer detection," said President and CEO, Olivia Cheng. "With a growing international demand for a complete breast MRI solution, we have many partners awaiting this certification," adds Cheng. "Currently, centers without the Aurora system provide breast MRI on traditional whole body scanners that require accessory products from a variety of manufacturers that are poorly interfaced and often difficult to use. Breast radiologists now have a truly integrated breast MRI solution," said Cheng.
ISO is the International Organization for Standardization, a network of the national standards institutes of 156 countries. ISO achieves international consensus on standards used to certify the safety and efficacy of products and processes including design and development, manufacturing, delivery and service.
CMDCAS (Canadian Medical Devices Conformity Assessment System) requires that certain medical devices be designed and manufactured under a registered quality management system (QMS) that meets the criteria of the international standards: ISO 13485-98 and ISO 13488-98.`
MDD/CE Marking has been in effect since 1998, and it is no longer permitted for medical devices to be offered for sale in Europe without CE marking. Aurora Imaging Technology's quality system and overall operations were assessed by TUV America, which granted the ISO, CMDCAS and MDD CE Marking certifications.
The Aurora System is designed to be located within the breast care center where it is readily available to specialized physicians and their patients. As a diagnostic imaging tool, the Aurora(R) 1.5T Dedicated Breast MRI System with Bilateral RODEO is ideal for a wide range of indications in breast disease management including, but not limited to:
-- Detection of cancer in higher risk women, especially those with dense breast tissue or for whom mammography is technically limited due to anatomic factors, such as surgical alteration or implants.
-- Determining the extent of cancer for better treatment planning.
-- Evaluation of patients to determine if there are positive surgical margins indicating residual cancer.
-- Monitoring cancer response in patients being given neoadjuvant chemotherapy.
-- Evaluation of breast implant integrity (The Aurora, with RODEO technology which suppresses fat and normal ductal tissue, combines easily with silicone-suppression sequences, allowing both implant integrity assessment and cancer detection in both breasts in a single MRI examination).
About Aurora Imaging Technology, Inc.
Aurora Imaging Technology, Inc. (www.auroramri.com) is a private company based in North Andover, Massachusetts. Aurora is the developer and manufacturer of the Aurora(R) 1.5T Dedicated Breast MRI System with Bilateral RODEO(R), the first and only FDA cleared MRI system designed specifically for breast imaging.
The Aurora system provides the complete breast MRI solution including a specialized physician workstation (rapid interpretation review capability using multiplanar reformations, MIP, 3-plane motion corrected subtraction, dynamic analysis tools and volume calculation) and integrated biopsy/interventional capability. Aurora Imaging Technology, Inc. partners with the nation's finest breast care centers to provide the ultimate in the detection, diagnosis and treatment of breast cancer.
[ Back To TMCnet.com's Homepage ]
|
Find Solutions for Enterprises, SMBs & Service Providers at the INTERNET TELEPHONY Conference and EXPO West, September 16-18, 2008. Los Angeles, California.
