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.
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Stroke MRI Study Assesses Impact of Motion Artifacts Upon AI and Radiologist Lesion Detection
July 16th 2025Noting a 7.4 percent incidence of motion artifacts on brain MRI scans for suspected stroke patients, the authors of a new study found that motion artifacts can reduce radiologist and AI accuracy for detecting hemorrhagic lesions.