A U.S. Food and Drug Administration advisory panel has backed Senseonics Holdings Inc.'s Eversense, a long-term implantable continuous glucose monitoring system for diabetic patients.
The Clinical Chemistry and Clinical Toxicology Devices panel, which included independent medical experts, voted unanimously that the benefits of Eversense outweigh the risks and that the system is safe and effective.
The Eversense system is an implantable continuous glucose monitoring system utilizing a sensor that lasts for up to 90 days.
Senseonics showed the safety, efficacy and a favorable risk-benefit profile for Eversense through real-world data from patients using the system in Europe and data from the U.S. PRECISE II study.
Germantown, Md.-based Senseonics Holdings is a medical technology company focused on the design, development and commercialization of glucose monitoring products.