At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States.The FDA is committed to advancing novel products that leverage digital technology to improve patient care, FDA Commissioner Dr. Scott Gottlieb said in a statement. These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms.The company has been waiting on this clearance since November 2016. Its very significant for the company, which is already selling its second-generation device in Europe, the Middle East, and Africa.We actually have been commercializing the product for about 21 months in Europe, so weve got some experience with our manufacturing, our quality systems, and we do that predominately through our partner Roche, Senseonics President and CEO Tim Goodnow told MobiHealthNews. And now the US is our largest market. Its about 75 to 80 percent of the global glucose monitoring market opportunity for CGM, and were happy to be here.

Source: Click here

Share this article

Facebook Comments