The San Diego developer of the ultrasound contrast medium Imavist has provided documentation requested by the FDA to support the companyπs application to market the agent in the U.S. The FDA had reviewed a new drug application for Imavist and found
The San Diego developer of the ultrasound contrast medium Imavist has provided documentation requested by the FDA to support the companyπs application to market the agent in the U.S. The FDA had reviewed a new drug application for Imavist and found it to be approvable upon satisfactory response to issues identified in the review process. Alliance and Schering of Germany are developing Imavist jointly. Alliance believes the current submission fully addresses the issues noted by the FDA, and the company hopes to receive final approval later this year.
MRI-Based AI Radiomics Model Offers 'Robust' Prediction of Perineural Invasion in Prostate Cancer
July 26th 2024A model that combines MRI-based deep learning radiomics and clinical factors demonstrated an 84.8 percent ROC AUC and a 92.6 percent precision-recall AUC for predicting perineural invasion in prostate cancer cases.
Breast MRI Study Examines Common Factors with False Negatives and False Positives
July 24th 2024The absence of ipsilateral breast hypervascularity is three times more likely to be associated with false-negative findings on breast MRI and non-mass enhancement lesions have a 4.5-fold likelihood of being linked to false-positive results, according to new research.
Can Polyenergetic Reconstruction Help Resolve Streak Artifacts in Photon Counting CT?
July 22nd 2024New research looking at photon-counting computed tomography (PCCT) demonstrated significantly reduced variation and tracheal air density attenuation with polyenergetic reconstruction in contrast to monoenergetic reconstruction on chest CT.