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Subject to the applicant adequately addressing this concern, we would agree that the technology meets the cost criterion and are proposing to approve the ATS 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
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[Google Scholar] Prete R, Long SL, Gallardo ALet al
doi: 10.1016/j.ejps.2018.03.025
doi: 10.1352/1944-7558-117.3.233
3d) closely matches that of the theoretical isotope distribution of unlabeled TS (Fig
