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.

Covidien Ltd. has received tentative FDA approval for the Abbreviated New Drug Application (ANDA) for its generic version of Cardiolite. The product, a Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, is a myocardial perfusion imaging-agent that is designed for detecting coronary artery disease. The product would receive final approval once Cardiolite’s marketing exclusivity period expires on July 29.