A panel for the FDA is slated to review Senseonics‘ (NYSE:SENS) premarket approval application for its Eversense implantable continuous glucose monitoring system on March 29.
The company’s device sends glucose data every five minutes to a transmitter, which then communicates that information to a mobile app, displaying the values in the real-time. The Eversense system also includes an alarm to warn the user if they’re approaching hyper- or hypo-glycemia.
In a 90-day trial involving 90 patients with Type I and Type II diabetes, Senseonics showed that the implantable CGM was safe and accurate compared to reference glucose values.
“The scheduling of the advisory panel represents a meaningful milestone toward offering patients in the U.S. a long-term, implantable CGM system,” president & CEO Tim Goodnow said in prepared remarks. “We are excited for the opportunity to discuss the data in support of the Eversense PMA with the panel. We believe the Eversense system’s value to people with diabetes will resonate with the panel as it has with users in Europe.”
