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Food and Drug Administration (FDA) as breakthrough devices.[1] As described in the notice with comment period (the Procedural Notice), the voluntary TCET pathway aims to streamline efforts between CMS, the FDA, and manufacturers of certain FDA-designated breakthrough devices to more efficiently advance breakthrough devices through the CMS coverage determination processes using a coverage with evidence development (CED) approach

The SELECT trial demonstrated that semaglutide 2.4 mg reduced major adverse cardiovascular events (heart attack, stroke, and cardiovascular death) by 20% in adults with overweight or obesity and established heart disease (Lincoff et al., SELECT trial, New England Journal of Medicine , 2023)