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The compound remains in a regulatory gray area: recognized as safe, but without the efficacy data needed for pharmaceutical approval

We agree that the technology meets the cost criterion and therefore are proposing to approve the Ceribell Delirium Monitor for new technology add-on payments 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

dioscoridis ) and Erigeron bonariensis ( E

Abstract Introduction: Antimicrobial resistance is a pressing global concern that has led to the search for new antibacterial agents with novel targets or non-traditional approaches