Acusphere has submitted a New Drug Application (NDA) to the FDA for approval to market Imagify (Perflubutane Polymer Microspheres for Injectable Suspension), an ultrasound imaging agent for the detection of coronary artery disease, which could prove as accurate as nuclear stress testing.

ProHance is a macrocyclic, nonionic, gadolinium-based magnetic resonance imaging (MRI) contrast agent designed for use in MRI in adults and children over two years of age to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. ProHance is also indicated for use in MRI in adults to visualize lesions in the head and neck.

The FDA granted tentative approval for Covidien’s Abbreviated New Drug Application (ANDA) for its Kit for the Preparation of Technetium Tc 99m Sestamibi Injection. Covidien’s tentatively approved product is a generic of Cardiolite, which is a myocardial perfusion imaging agent used for detecting coronary artery disease.

The FDA recently approved Covidien’s contrast delivery system with radiofrequency identification (RFID) technology ...

The ACIST CVi Contrast Delivery System provides one injection system for all cardiac and vascular angiography procedures. The variable-rate ACIST CVi system aims to provide ease of operation for clinicians, while obtaining quality images with less contrast used and delivered to the patient.

The FDA cleared GE Healthcare’s new LightSpeed CT750 HD, a high-definition CT scanner that is said to produce images 100 ...