Senseonics Submits PMA Application for 180 | 合法醫療器材資訊網

2020年10月5日—SenseonicsSubmitsPMAApplicationfor180-DayEversenseSystemtotheFDA...GERMANTOWN,Md.--(BUSINESSWIRE)--Senseonics ...

Senseonics Submits PMA Application for 180-Day Eversense System to the FDA

PROMISE Study Demonstrated Strong Accuracy Performance, Consistent with Current Eversense CGM System

GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the Premarket Approval (PMA) supplement application to extend the wearable life of the Eversense® CGM System to 180 days was submitted to the United States Food and Drug Administration (FDA) on September 30. Summary accuracy results from the PROMISE Clinical Study for the 180-day product were also announced.

The PMA application is supported by clinical data generated from the PROMISE Clinical Study. The 181 study participants had th...