Aurora(R) 1.5Tesla Dedicated Breast MRI System Has Received 501(k) Clearance From FDA

Main Category: MRI / PET / Ultrasound
Also Included In: Breast Cancer;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 05 Nov 2008 - 3:00 PDT

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Aurora Imaging Technology Inc. is proud to announce that the Aurora® 1.5Tesla Dedicated Breast MRI System has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) for AuroraSPECTROSCOPY™, the company's breast magnetic resonance (MR) spectroscopy package. The availability of AuroraSPECTROSCOPY will provide Aurora Breast MRI the capability to perform in vivo breast MR spectroscopy (MRS) and MR spectroscopic imaging (MRSI). AuroraSPECTROSCOPY was developed to supplement Aurora Breast MRI by further improving the image specificity of this groundbreaking technology. The Aurora Breast MRI remains the only FDA-cleared dedicated breast MRI system specifically designed for the detection, diagnosis and management of breast disease alone.

"The introduction of AuroraSPECTROSCOPY is another example of Aurora's commitment to offering promising tools and technology to aid medical professionals in combating breast disease through early detection and improved treatment planning," said Olivia Ho Cheng, president and chief executive officer, Aurora Imaging Technology. "Medical imaging technology for breast disease has come a long way since the introduction of breast MRI in the 1980s. We are so proud of the improvements Aurora has contributed to the medical field thus far and will continue to deploy advanced technology to maintain the Aurora Breast MRI as one of the most sophisticated imaging tools specifically designed to assist in improving breast cancer statistics."

According to the American Cancer Society (ACS), more than 180,000 new cases of invasive breast cancer are expected to occur among women in the U.S. in 2008. Although breast cancer death rates have steadily decreased in women since 1990, breast cancer remains the second leading cause of cancer-related mortalities and the leading cancer diagnosed in women today.

"Like breast MRI, spectroscopy is a technology that also has shown promise in breast cancer," added Cheng. "Although the use of spectroscopy is in its very early stages for the indication of breast cancer, clinical studies such as those published in the medical journal of Radiology have supported the potential of spectroscopy to improve image specificity in detecting malignant breast tissue."

About Aurora Imaging Technology Inc.

Aurora Imaging Technology Inc. is a private company based in North Andover, Mass. 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 health centers to provide the ultimate in the detection, diagnosis, biopsy and treatment management of breast disease. The Aurora Breast MRI is in clinical use at a rapidly growing number of leading breast health centers in the U.S., Europe and Asia.

Aurora Imaging Technology Inc.

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