The FDA's approval was supported by data specifically gathered in patients aged <2 years. The 0.1mmol/kg dose significantly improved the visualization and morphologic assessment of CNS lesions as seen in older pediatric patients and adults.
Across studies, the pooled sensitivity of MR imaging was 0.90 and the specificity was 0.88 for differentiating tumors staged T1 or lower from those staged T2 or higher.
After adjusting for gender, age, education level, baseline neurocognitive performance, and others, the authors reported gadolinium exposure was not a significant predictor of cognitive decline, dementia, diminished neuropsychological performance or diminished motor performance
The researchers found that the mass spectrometry-derived Aβ42 values showed higher correlations with the modified Aβ42-INNOTEST, Aβ42-FL, Aβ42-EI, and Aβ42-MSD assays versus the classic Aβ42-INNOTEST assay.
The FDA reviewed a 510(k) premarket submission for the device by Siemens and based its clearance on comparison to a predicate device and sample clinical images.
Tagitol V, a low-volume fecal tagging agent, opacifies remaining stool in the colon for CT imaging. It will be available as a 40% w/v oral suspension in boxes containing three 20mL bottles.
The approval was based on a study (n=51) which showed that at the standard dose, the pharmacokinetic and safety profiles for this gadolinium-based contrast agent were similar for patients under the age of 2 and in older children and adults.
Varibar Nectar — with target viscosity 300 CPS — comes in an apple flavor for improved patient compliance and is designed to provide the least coating properties necessary to visualize the swallowing process.
The Embrace Neonatal MRI System is specifically designed for imaging of the neonatal head (head circumference up to 38cm and weight of 1 - 4.5kg).
The approval was supported by three prospective studies that showed aminolevulinic acid-induced fluorescence was highly predictive for visualizing malignant tissue as verified by histopathology of biopsied fluorescent tissue.
Some of these studies evaluated GBCA use for durations >1 year and showed that gadolinium is retained in organs such as the brain, bones, and skin.
Digital imaging has improved diagnostic capability of mammograms but the percentage of false-positives is up, too, according to a study published online in Radiology.
Bracco Diagnostics announced that the Food and Drug Administration (FDA) has approved Varibar Pudding (barium sulfate) oral paste for modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology.
Many emergency physicians are performing low-value services, despite patients being deemed low-risk. The findings come from a cross-sectional sample survey of nearly 800 emergency physicians.
For men with high serum prostate-specific antigen, multi-parametric magnetic resonance imaging (MP-MRI) is more sensitive but less specific than transrectal ultrasound guided prostate biopsy (TRUS-biopsy) for detecting clinically significant cancer, and can be used as a triage test to avoid unnecessary biopsy, according to a study published online in The Lancet.
The FDA has received reports of serious adverse events which describe medication dosing inaccuracies and other mechanical problems with the pump that have led to patient injury and death.
Bracco Diagnostics announced that the Food and Drug Administration (FDA) has lifted the contraindication for use of Lumason (sulfur hexafluoride lipid-type A microspheres) in patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts.
Otsuka and Interpharma Praha announced the coming launch of Oraltag (iohexol) for Oral Solution indicated for use in computed tomography (CT) of the abdomen and pelvis to opacify bowel loops and delineate between normal loops and adjacent organs or areas of suspected pathology.
The Food and Drug Administration (FDA) has approved Netspot (Advanced Accelerator Applications), a radioactive diagnostic agent for positron emission topography (PET) imaging. The probe will aid in locating tumors in patients with somatostatin receptor positive neuroendocrine tumors (NETs), a rare set of tumors which may or may not be cancerous.
Bayer announced that the Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients, including term neonates.
A series of hand signals has been developed for use during computed tomography (CT) or angiographic procedures, according to an article published online April 20 in the Journal of Medical Radiation Sciences.
For patients with suspected coronary artery disease, the prognostic value of cardiac noninvasive tests (NITs) varies by test type and sex, according to a study published online April 4 in the Journal of the American College of Cardiology.
Bracco Diagnostics announced that the Food and Drug Administration (FDA) has expanded the use of Lumason for use in ultrasonography of the liver for characterization of focal liver lesions in adults and pediatric patients.
Cairn Diagnostics announced the launch of 13C-Spirulina Gastric Emptying Breath Test (GEBT) for measuring the rate of solid-phase gastric emptying and as an aid in the diagnosis of gastroparesis in symptomatic adults.