Advanced Magnetics’ bid to expand the labeling of MRI liver contrast agent Feridex I.V. has failed. The FDA has declared the company’s supplemental new drug application “not approvable.” Advanced Magnetics had hoped to increase
Advanced Magnetics’ bid to expand the labeling of MRI liver contrast agent Feridex I.V. has failed. The FDA has declared the company’s supplemental new drug application “not approvable.” Advanced Magnetics had hoped to increase the appeal of Feridex, which has floundered in the marketplace, by including differentiation of liver lesions as benign or metastatic and changing the dosing regimen to allow more rapid infusion. The agent, which was originally approved by the FDA on Aug. 30, 1996, is marketed in the U.S. by Berlex Laboratories, a subsidiary of Schering of Germany.
Could Virtual Non-Contrast Images from Photon-Counting CT Reduce Radiation Dosing with CCTA?
March 28th 2024Emerging research on coronary artery calcium scoring for the assessment of coronary artery disease (CAD) suggests the use of virtual non-contrast images from photon-counting CT may lead to a nearly 20 percent reduction in radiation dosing.
FDA Clears CT-Based AI Tools for PE Detection and Stroke Severity Assessment
March 26th 2024The artificial intelligence (AI) modalities CINA-iPE and CINA-ASPECTS may facilitate improved detection of incidental pulmonary embolism and stroke evaluation, respectively, based on computed tomography (CT) scans.