Browsing Tag
Okays
2 posts
FDA Okays 6-Month Implanted Eversense CGM for Diabetes
The US Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months. The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new…
FDA Okays Evolocumab Add-On for FH in Children Aged 10 and Up
The US Food and Drug Administration (FDA) has approved evolocumab (Repatha, Amgen), a PCSK9 inhibitor, for use as add-on treatment to diet alone or with other therapies for children 10 years of age and older with either heterozygous or homozygous familial hypercholesterolemia (FH). Approval was based on randomized trials of evolocumab in both types of…