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Animal reproduction studies have shown fetal skeletal and cardiovascular effects at high doses, though direct human pregnancy data remains extremely limited because pregnant individuals are excluded from clinical trials

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For the purposes of the device pass-through evaluation process, CMS evaluates the nominated device that is the subject of an application, not a category of devices, to determine if the device meets the eligibility criteria described in 419.66

Alternatively, switch to injectable semaglutide to simplify the medication schedule