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. It’s 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 we’ve 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. It’s about 75 to 80 percent of the global glucose monitoring market opportunity for CGM, and we’re happy to be here.”
Goodnow says the approval took a little while because the implantable CGM is novel and the FDA elected to convene a panel meeting of medical experts.
“They requested that because they had never approved an implantable product before for glucose monitoring. So [they held the panel] to make sure that they asked all the right questions and that they had representatives from the medical community to buy-in on their decisions,” Goodnow said. “And I think that really empowered the FDA to feel strongly about moving quickly to that final approval.”
The new clearance is for an older Senseonics device. It covers the 90-day monitoring model, whereas the version on sale in Europe lasts for 180 days.
“We are out with the 180-day product in Europe and we will be bringing it to the United States,” Goodnow said. “But [the 90-day device] is a very attractive and compelling product for people with diabetes.”
Additionally, since Senseonics submitted its application prior to Dexcom’s landmark clearance for non-adjunctive use, Eversense is not currently cleared for use without a fingerstick glucometer.
Both of these are likely temporary situations: now that Senseonics has its first clearance, both non-adjunctive and longer-life models should move through the agency more quickly.
“When the Dexcom decision came forward we met with the FDA and they said we’re certainly free and able,” Goodnow said. “But unfortunately it’s that they would consider a material change so they would have to reset the clock. And we said, we don’t want to do that. We’ll submit for that dosing claim as a supplement right after we get approval.”
Unlike in Europe, where Senseonics has commercialized its devices through a partnership with Roche, in the United States it will sell directly to endocrinologists.
“Roche is a great distribution partner in Europe, but we will be distributing it ourselves in the United States,” Goodnow said. “There’s 2,000 doctors to call on, high quality sales reps can cover about 20, so we need about 100 to cover that space. And 100 is a small enough sales force that a company like Senseonics can handle it.”
He says the company expects to have the first device in patients’ hands by the end of July.