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( We agree with the applicant that the Nelli Seizure Monitoring System meets the cost criterion and are therefore proposing to approve the Nelli Seizure Monitoring System 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

[DOI] [PubMed] [Google Scholar] 161.Iborra M., Moret I., Rausell F., Bastida G., Aguas M., Cerrillo E., Nos P., Beltran B

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