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With regard to the substantial clinical improvement criterion, the applicant asserted that XENOVIEW TM represents a substantial clinical improvement over existing technologies because HP 129 Xe gas for oral inhalation with MRI offers an effective option for patients with pulmonary challenges to obtain quantitative information regarding their lung ventilation as it relates to their progression of disease without subjecting the patient to ionizing radiation or the half-life of nuclear imaging agents

S.BoutronI.et al (2019)

Using higher doses or off-label products may increase the risk

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