An FDA advisory panel voted unanimously to recommend approval for Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor, Eversense, the company touted this week.
The panel of medical experts voted 8-0 that the benefits of the technology outweigh the risks and that the system, which works for up to 90 days, is safe and effective.
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 hypoglycemia.
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.
“We are pleased that the advisory panel believes in the benefits of the Eversense system. We are confident that the benefits of the system – longest life sensor, sustained accuracy, predictive glucose alerts, removable smart transmitter, gentle-on-skin adhesive – can be life-changing for people with diabetes, and this is another step toward offering these benefits to patients in the U.S.,” president & CEO Tim Goodnow said in prepared remarks.
SENS shares jumped 20.1% after the markets closed yesterday, trading at $3.62 apiece.
