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Sonus meets with FDA on EchoGen
It could be as long as 10 months before Sonus Pharmaceuticals gets its EchoGen ultrasound contrast agent on the market, as it moves to comply with the Food and Drug Administration’s concerns about the agent’s new drug application (NDA). Sonus
It could be as long as 10 months before Sonus Pharmaceuticals gets its EchoGen ultrasound contrast agent on the market, as it moves to comply with the Food and Drug Administrations concerns about the agents new drug application (NDA). Sonus of Bothell, WA, met with the FDA on April 27 to discuss the NDA after receiving a not-approvable letter for EchoGen in February (SCAN 3/18/98).
Sonus reported that it plans to submit an amendment to EchoGens NDA in the next two to four months to respond to the FDAs concerns regarding the manufacturing processes for EchoGen, including chemistry and analytical methods validation, as well as the companys analysis of animal and clinical data in the application. Once Sonus submits the amendment, the FDA could take up to six months to review it before rendering a decision.
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.
