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The applicant stated that CMS should consider the VersaVue TM Single-Use Flexible Cystoscope application using the same standard applied to other recent decisions for disposable devices and determine that the improved patient outcomes and reduced patient risk associated with the disposable nominated device in comparison with reusable devices is a substantial clinical improvement

Further studies are requisite to confirm their efficacy and safety

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In comparison, 20% of a large HBV-positive Veterans Affairs (VA) cohort got tested for HDV, of whom 3% tested positive