Sonus Pharmaceuticals has announced that the Food and Drug Administration will not require a Medical Imaging Drug Advisory Committee (MIDAC) meeting to complete the review of the Bothell, WA-based company's EchoGen ultrasound contrast agent. In reaching
Sonus Pharmaceuticals has announced that the Food and Drug Administration will not require a Medical Imaging Drug Advisory Committee (MIDAC) meeting to complete the review of the Bothell, WA-based company's EchoGen ultrasound contrast agent. In reaching its decision, the FDA indicated that it was comfortable with the general issues regarding the class of products including ultrasound contrast agents, according to the company.
The comfort level apparently evolved out of a Radiology Device Advisory Committee meeting held earlier this year for FS069 (now Optison), an ultrasound contrast agent from Molecular Biosystems (SCAN 3/5/97). The ruling bypassing the need for an advisory committee meeting was exclusive to EchoGen, however, said Kelly Ford, communications director for Sonus. Officials at Molecular Biosystems were unavailable for comment. Sonus would not speculate on how much time the FDA's decision would cut off EchoGen's review time.
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.