8 results found
https://www.federalregister.gov/documents/2019/11/12/2019-24138/medicare-program-changes-t…

…y exercises, in addition to providing standard step count and high-acceleration events that may indicate a fall. A temperature sensor monitors the skin temperature near the joint. TracPatch is described by the applicant as a 24/7 remote monitoring wearable device that captures a …

https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-…

… instead interquartile ranges ( 90 FR 18099 ). The applicant summarized adverse events reported in Cauchy et al. (2011) and Crooks et al. (2022), as well as a multicenter retrospective cohort study and the AURLUMYN TM prescribing information. The applicant also referenced the NDA…