Lymphoseek Approval Expanded to Pediatric Patients
The approval was based on data from a phase 2 trial that assessed Lymphoseek in pediatric patients with melanoma, RMS, or other solid tumors.
Imaging Agents
Pafolacianine Sodium Gets Priority Review for Ovarian Cancer Detection During Surgery
Pafolacianine sodium binds to folate receptors commonly found on many cancers, including ovarian and lung cancers, and illuminates the cancerous lesions under near-infrared light.
Gadavist Imaging Bulk Package Approved for Multi-Patient Dosing
Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers.
Lumason Approved for Pediatric Patients With Suboptimal Echocardiograms
The Food and Drug Administration (FDA) has approved Lumason (sulfur hexafluoride lipid-type A microspheres; Bracco Diagnostics Inc.), an ultrasound enhancing agent, for use in echocardiography to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border in pediatric patients with suboptimal echocardiograms. Previously, the treatment was only approved for…
Some Pregnant Women Exposed to Common MRI Contrast Agent
Exposure often occurs early in the pregnancy, likely before pregnancy has been recognized
Varibar Thin Liquid Gets FDA Approval for Modified Barium Swallow Studies
The Food and Drug Administration (FDA) has approved Varibar Thin Liquid for oral suspension (barium sulfate; Bracco Diagnostics Inc.) for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. Varibar Thin Liquid is a radiographic contrast agent that is supplied as a powder…
Contrast Agent Gadavist Approved for Use in Cardiac MRI
The Food and Drug Administration (FDA) has approved Gadavist (gadobutrol; Bayer) injection for use in cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). The approval was based on data from two phase 3 multicenter, open-label trials that…
Unique Total-Body Imaging Scanner uEXPLORER Cleared by FDA
The uEXPLORER combines positron emission tomography (PET) with X-ray computed tomography (CT) allowing for imaging of the entire body at the same time.
Artificial Intelligence can Detect, Classify Acute Brain Bleeds
An artificial intelligence system can diagnose and classify intracranial hemorrhage (ICH).
MRI Indicates Sacroiliitis in Some Healthy Individuals
Healthy volunteers, patients with chronic back pain, and runners did not have deep bone marrow edema lesions, but 89.4% of axial SpA patients and 14.3% of women with postpartum back pain did have lesions.
