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We invite public comments on whether the Ceribell Delirium Monitor meets the cost criterion and our proposal to approve new technology add-on payments for the Ceribell Delirium Monitor for FY 2024 subject to the technology receiving FDA marketing authorization as a Breakthrough Device for the indication corresponding to the Breakthrough Device designation by July 1, 2023

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1 Introduction Neuroblastoma (NB) is the most common extracranial solid tumor in infants

32 This dysfunction theoretically could lead to an increased vulnerability to neurotoxins following exposure to sulfur-containing substances