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DuPont submits MAA for Definity
In its continued effort to bring ultrasound contrast agent Definity to market, DuPont Pharmaceuticals has filed a marketing authorization application (MAA) for the agent with the European Medicines Evaluation Agency (EMEA). The application is based on
In its continued effort to bring ultrasound contrast agent Definity to market, DuPont Pharmaceuticals has filed a marketing authorization application (MAA) for the agent with the European Medicines Evaluation Agency (EMEA). The application is based on seven multicenter phase III clinical trials that included 610 patients at 52 U.S. medical centers and covers the use of Definity for contrast-enhanced ultrasound imaging of the heart and abdomen.
EMEAs review arm, the Committee for Proprietary Medicinal Products (CPMP), will examine the North Billerica, MA, companys application. If cleared by the CPMP, DuPont will be able to sell Definity in all of the European Union countries. DuPont has also filed a new drug submission (NDS) for Definity with the Health Protection Branch of Health Canada, and, in 1998, filed an NDA with the Food and Drug Administration (SCAN 12/16/98).
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.
