Aurora Receives FDA Clearance for Spectroscopy Technology

Aurora Imaging Technology of North Andover, Mass., has received US Food and Drug Administration (FDA) clearance for their new spectroscopy technology. Aurora Imaging announced that the Aurora 1.5Tesla dedicated breast MRI (magnetic resonance imaging) system received 501(k) clearance from the FDA for the AuroraSpectroscopy, the company’s breast magnetic resonance spectroscopy package. The availability of AuroraSpectroscopy will provide Aurora Breast MRI the capability to perform in vivo breast MR spectroscopy and MR spectroscopic imaging (MRSI). 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.