Regulatory news: Aurora gets nod from China for breast MRI system

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Aurora Imaging Technology announced 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). Receipt of the certificate will now allow Aurora to sell its product in the country’s medical device market which is estimated at close to $3.5 billion. The Aurora System is a fully integrated MRI system designed specifically and exclusively to image the breast and optimized for breast imaging and interventional procedures.