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Zhang B, Zhou WJ, Gu CJ, et al

Zappettini S, Faivre E, Ghestem A, Carrier S, Buee L, Blum D, et al

Under the proposed three-phase framework, manufacturers of breakthrough devices accepted into the TCET pathway would enter a period of transitional coverage through a TCET national coverage determination (NCD), during which the devices manufacturer would be able to generate evidence for CMS to use to determine the breakthrough devices post-TCET final coverage status

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