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Albunex wins European panel's nod
Molecular Biosystems has received an approval recommendation fromEurope's Committee for Proprietary Medicinal Products (CPMP) forits Albunex ultrasound contrast agent, which will be marketedin Europe as Infoson. Infoson's application will now go to
Molecular Biosystems has received an approval recommendation fromEurope's Committee for Proprietary Medicinal Products (CPMP) forits Albunex ultrasound contrast agent, which will be marketedin Europe as Infoson. Infoson's application will now go to membercountries of the European Union, whose regulatory agencies generallyfollow CPMP recommendations.
San Diego-based MBI took over regulatory responsibility forInfoson after it reacquired European marketing rights to the agentlate last year from Hafslund Nycomed, which had shepherded Infosonthrough European clinical trials. Nycomed apparently wished tofocus on commercial development of its own ultrasound contrastagents, according to MBI president and COO Bobba Venkatadri.
MBI is looking for another marketing partner to handle Infosonin the regions once covered by Nycomed: Europe, Africa, the MiddleEast, India, and the former Soviet Union. MBI is in discussionswith several firms, including U.S. marketing partner MallinckrodtMedical, and hopes to have a deal sewn up by May, Venkatadri said.
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.
