Therapy Areas: Devices
FDA Advisory Committee Votes Favorably on Senseonics Eversense System
4 April 2018 - - Germantown, Maryland-based glucose monitoring systems specialist Senseonics Holdings, Inc. (NYSE MKT: SENS) has received a favorable result from the US Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices meeting on the Eversense system, a first of its kind implantable continuous glucose monitoring (CGM) system utilizing a sensor that lasts for up to 90 days, the company said.
The panel, comprised of independent medical experts, voted unanimously, 8 to 0, that the benefits outweigh the risks, voted unanimously, 8 to 0, that the system is safe, and voted unanimously, 8 to 0, that the system is effective.
The company demonstrated safety, efficacy and a favorable risk benefit profile for Eversense through real world data from patients currently using the system in Europe and data from the US PRECISE II study.
The study is considered one of the largest studies of a CGM system in the world, including over 2 million sensor glucose readings, from 90 participants at eight clinical centers.
Senseonics is focused on the development and commercialization of Eversense, a long-term, implantable continuous glucose monitoring system for people with diabetes.
Login
Username:

Password:


Related Headlines