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With respect to the newness criterion at 419.66(b)(1), FDA granted the applicant 510(k) clearance for the LithoVue TM Elite System on February, 2023

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Considering the public input received and further internal analyses conducted, we proposed to make the following modifications to the Overall Hospital Quality Star Rating methodology: (1) implement a 4-star cap for hospitals in the lowest-performing quartile of the Safety of Care measure group for the 2026 Overall Hospital Quality Star Rating, and (2) implement a blanket 1-star reduction for hospitals in the lowest-performing quartile of the Safety of Care measure group for the 2027 Overall Hospital Quality Star Rating and thereafter