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Bracco

Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Shots: Bracco Imaging has received the US FDA 510(k) clearance & Health Canada authorization for VueJect, its dedicated ultrasound contrast delivery system designed specifically for cardiology imaging VueJect is designed to improve workflow efficiency, reduce operator variability & enable continuous administration of ultrasound contrast agents for more consistent enhancement during cardiac imaging VueJect will initially…

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Bracco

Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Shots: China’s NMPA has approved SonoVue for use in hysterosalpingo contrast sonography (HyCoSy) to detect tubal issues & uterine problems A meta-analysis of 24 studies in 1358 women with infertility & 2661 fallopian tubes showed superior diagnostic performance of HyCoSy with SonoVue, with pooled sensitivity of 93%, specificity of 90%, & accuracy of 96% vs…

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Bracco Imaging & Subtle Medical’s AiMIFY Receives the European CE Mark Approval for Enhanced Brain MRI 

Shots: Bracco Imaging & Subtle Medical have received the European MDR CE Mark approval for their AI-powered AiMIFY software for brain MRI; phased commercial availability expected from late 2025 to early 2026 AiMIFY has depicted consistent efficacy across extensive validation data, incl. diverse pts demographics, pathologies, lesion sizes, MRI sequences, scanner vendors, & acquisition orientations…

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