Aurora Imaging Technology Announces Approval in China.Breast MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. Leader Can Sell in One of World's Fastest Growing Economies NORTH ANDOVER, Mass. -- Aurora Imaging Technology, Inc. announced today its receipt of a Registration Certificate for its Aurora[R] 1.5T Dedicated Breast MRI System from the State Food and Drug Administration The State Food and Drug Administration (SFDA Simplified Chinese: 国家食品药品监督管理局) is founded on the basis of the State Drug Administration. of the People's Republic of China (SFDA SFDA State Food and Drug Administration (China) SFDA Saudi Food & Drug Authority ). This agency is China's equivalent of the US Food and Drug Administration. Receipt of the Certificate will now allow Aurora to sell its product into one of the world's fastest growing economies with a medical device market estimated at close to $3.5 billion. One third of medical devices currently imported to China come from the United States. With the recent introduction of its proprietary SpiralRODEO[TM] image acquisition technology, Aurora is the leading innovator in the breast MRI industry. "We are very excited about the opportunity to bring our technology to a medical device market which is, after the US and the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , the largest in the world," said Olivia Ho Cheng, Aurora's president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "With a higher incidence of dense breast tissue in Asian populations, which can make mammography mammography, diagnostic procedure that uses low-dose X rays to detect abnormalities in the breasts. The early diagnosis of breast cancer made possible by the routine use of mammography for screening women increases a woman's treatment alternatives and improves her less conclusive, we believe that the Aurora System will be tremendously valuable to the improvement of breast cancer care in the Chinese population." The Aurora System is the only fully integrated MRI system designed specifically and exclusively to image the breast and optimized for breast imaging and interventional procedures. Some of the proprietary and distinguishing features of the Aurora System include: 1) an ellipsoid magnetic shim that provides coverage of both breasts, the chest wall and bilateral axillary lymph nodes The Axillary lymph nodes are of large size, vary from twenty to thirty in number, and may be arranged in the following groups:
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 SpiralRODEO[TM] is ideal for a wide range of indications in breast disease management including, but not limited to: * Detecting or excluding the existence of cancer in high risk women * Characterizing indeterminate clinical or mammographically detected abnormalities * Determining the extent of cancer for treatment planning * Detecting occult cancer occult cancer 1 Occult primary malignancy, see there 2. Clinically inapparent malignancy, pathologist's tumor A lesion defined as malignant by histologic criteria, which is an incidental discovery that occurs either when a Pt is being evaluted for other reasons, or * Evaluating patients for residual disease following surgery * Monitoring cancer response and the extent of residual disease after neoadjuvant chemotherapy * Evaluating implant integrity and detecting cancer in women with breast augmentation About Aurora Imaging Technology, Inc. Aurora Imaging Technology, Inc. (www.auroramri.com) is a private company based in North Andover, Massachusetts North Andover is a town in Essex County, Massachusetts, United States. The population was 27,202 at the 2000 census. History North Andover was first settled in 1646 and was officially incorporated in 1855. committed to expanding the fight against breast cancer. Aurora strives to manufacture the highest quality and most cost-effective breast MRI solutions and partners with a growing number of the nation's finest breast care centers to provide the ultimate in the detection, diagnosis, biopsy and treatment of breast cancer. The Aurora System is in clinical use at a growing number of leading breast care centers in the US, Europe and Asia. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion