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    Uro Pipeline: NDA submitted for non-metastatic castration-resistant PCa agent

     

     

    Study to evaluate 3-D printing of kidney, prostate models

    Stratasys announced that a new clinical study is being conducted with the New York University School of Medicine, New York, aimed at advancing diagnosis and treatment of complex kidney and prostate tumors through imaging and 3-D printing. The 2-year clinical trial is specifically targeted at analyzing how patient-specific multi-colored physical tumor models, printed on the Stratasys J750 3-D printer, can potentially change and improve the quality of patient care. Under the randomized, controlled study, researchers are 3-D-printing kidney and prostate cancer models for a sample of the participating 300 patients—measuring the specific impact each has on pre-surgical planning versus traditional 2-D visualization approaches. Subjects are separated into three treatment categories to analyze and compare conventional preoperative 2-D imaging, augmented reality models, and next-generation 3-D printed models. The study is expected to continue into 2018, according to Stratasys.

     

    FDA accepts supplemental NDA for bladder cancer detection agent

    The FDA has accepted the supplemental new drug application for Photocure ASA’s Cysview on a priority review basis. Photocure said it is looking to expand the label of Cysview to include its use in the outpatient setting to detect the recurrence of bladder cancer using a flexible cystoscope, the detection of carcinoma in situ, and the repeat administration of Cysview. The filing is a combination drug-device application with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System. With the FDA granting a priority review, a decision is expected in the first half of 2018. 

    Next: Imaging modality leads to changes in prostate cancer management

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