Senseonics Submits Eversense Continuous Glucose Monitoring system PMA to FDA
Senseonics has submitted to the FDA a Premarket Approval application for its Eversense CGM system.
The application hinges on a pivotal trial that has enrolled 90 adults with Type 1 or Type 2 diabetes at eight clinical centers.
The objective of the study is to demonstrate the safety and effectiveness of the Eversense CGM system over 90 days of continuous glucose sensor wear.
Results of the study will be presented at the Diabetes Technology meeting in November. — Cynthia Jessup