Senseonics Holdings announces that the extended life Eversense XL sensor that lasts up to 180 days has been implanted in the first US study participant as part of the clinical trial for pre-market application submission to the Food and Drug Administration. The study is intended to evaluate the safety and efficacy of the Eversense CGM system in people with diabetes over a 180-day period.
Approximately 180 study participants at up to 15 locations across the United States are planned to enroll in the study. The Eversense XL sensor previously received the CE Mark and is currently marketed to patients across the European Union.
Senseonics also announced that the company has completed its submission of PMA supplements to the FDA to secure an insulin dosing claim and to remove the contraindication related to the Magnetic Resonance Imaging (MRI) exposure on the 90-day system which is currently available in the United States.
For more information, visit Senseonics.