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The EU approval of Vueway for neonates, infants, and toddlers is a milestone for pediatric imaging as it allows high-quality MRI imaging at half the GBCA dose, supporting reduced gadolinium exposure in vulnerable young patients
Vueway’s gadopiclenol demonstrates safety and diagnostic performance by offering high stability, low dissociation risk, and 2.5–4× greater relaxivity than other macrocyclic GBCAs, enabling effective imaging…
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The company has reported dosing of the first patient in the US P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer
BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting
Building…
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The company has submitted a 510(k) application to the US FDA for its proprietary AI-assisted module designed for use with CapsoCam Plus
The CapsoCam Plus capsule endoscopy system is designed to visualize small bowel mucosa and detect abnormalities in adults and children (age ≥ 2 yrs)
The reading tool is expected to improve the…

