Healthcare Industry News: HSMN NewsFeed

Devices Radiology Regulatory

 News Release - December 6, 2006

Aurora Imaging Technology Announces Approval in China

Breast MRI Leader Can Sell in One of World's Fastest Growing Economies

NORTH ANDOVER, Mass.--(HSMN NewsFeed)--Aurora Imaging Technology, Inc. announced today its receipt of a Registration Certificate for its Aurora® 1.5T Dedicated Breast MRI System from the State Food and Drug Administration of the People's Republic of China (SFDA). 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, the largest in the world," said Olivia Ho Cheng, Aurora's president and CEO. "With a higher incidence of dense breast tissue in Asian populations, which can make mammography 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; 2) a precision gradient coil with the high linearity required for high resolution spiral reconstruction; 3) a patient-handling table that provides patient comfort and procedural utility; 4) a fully integrated Interventional System for MRI guided biopsy and localization; and 5) the user-friendly AuroraCAD(TM) computer-aided image display system designed to improve the accuracy and efficiency of diagnostic interpretations.

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® 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
  • 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. ( is a private company based in North Andover, Massachusetts 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.

Source: Aurora Imaging Technology

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