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FDA clears Nycomed contrast injector
Nycomed Amersham may be planning to bring a CT contrast injector system to market. Food and Drug Administration records indicate that the agency on Feb. 19 granted 510(k) clearance to the Anglo-Norwegian company for a device called Premica, listed as a
Nycomed Amersham may be planning to bring a CT contrast injector system to market. Food and Drug Administration records indicate that the agency on Feb. 19 granted 510(k) clearance to the Anglo-Norwegian company for a device called Premica, listed as a CT contrast media delivery system.
If Nycomed Amersham does bring such a product to market, it would compete with contrast injectors from companies owned by two of Nycomed's competitors in the contrast business, Schering and Mallinckrodt. Schering owns Medrad of Indianola, PA, while Mallinckrodt owns St. Louis-based Liebel-Flarsheim. Nycomed does not currently market a contrast delivery system.
Study Reaffirms Low Risk for csPCa with Biopsy Omission After Negative Prostate MRI
December 19th 2024In a new study involving nearly 600 biopsy-naïve men, researchers found that only 4 percent of those with negative prostate MRI had clinically significant prostate cancer after three years of active monitoring.
Study Examines Impact of Deep Learning on Fast MRI Protocols for Knee Pain
December 17th 2024Ten-minute and five-minute knee MRI exams with compressed sequences facilitated by deep learning offered nearly equivalent sensitivity and specificity as an 18-minute conventional MRI knee exam, according to research presented recently at the RSNA conference.
Can Radiomics Bolster Low-Dose CT Prognostic Assessment for High-Risk Lung Adenocarcinoma?
December 16th 2024A CT-based radiomic model offered over 10 percent higher specificity and positive predictive value for high-risk lung adenocarcinoma in comparison to a radiographic model, according to external validation testing in a recent study.
