Senseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA.
The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days.
Senseonics also noted that it has submitted the necessary documents to the FDA to land an insulin dosing claim and remove the contraindication related to MRI exposure for its 90-day sensor.
“We are pleased to have enrolled the first participant in this important study which demonstrates our continued progress in transforming CGM technology. This is the first study in the US in which participants are implanted with a single sensor designed to produce accurate continuous glucose measurements for half of a year,” president & CEO Tim Goodnow said in prepared remarks.
“Our submission of the supplements to secure the dosing claim and to remove the MRI contraindication for the current 90-Day Eversense system are significant step forward in reducing the burden of diabetes management and providing patients peace of mind,” he added.
Senseonics won CE Mark clearance in the European Union for its Eversense XL sensor in Sept. of 2017.