FDA clearance to Aurora® 1.5Tesla Dedicated Breast MRI System
The U.S. Food and Drug Administration has granted the 501(k) clearance to Aurora Imaging Technology Inc.’s Aurora® 1.5Tesla Dedicated Breast MRI System for AuroraSPECTROSCOPY™, the company’s package of breast magnetic resonance (MR) spectroscopy. The package was developed as an add-on for the Aurora Breast MRI in order to enhance the image specificity of this innovative technology. It continues to be the only dedicated breast MRI system cleared by FDA which is specifically designed to detect, diagnose and manage breast disease alone.
