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While FDA has approved other continuous glucose monitoring (CGM) systems, it just approved the first system that includes a fully implantable sensor to detect glucose.
The Eversense CGM system (Senseonic) utilizes a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said FDA Commissioner Scott Gottlieb, MD, in a statement from FDA. “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.”
Here’s how the implanted sensor works: it is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device (such as a smart phone or tablet) that is running a device-specific mobile app.
FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes and reviewed the device’s effectiveness by comparing readings obtained by the Eversense CGM system to those obtained by a laboratory-based glucose analyzer. The safety of the Eversense CGM system’s 90-day implantable sensor, and the procedure used to implant it, was also evaluated. The proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1%.
Plus, an FDA Advisory Committee, in a 8 to 0 vote, recommended that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes.
Meanwhile, FDA is creating a new and more carefully tailored regulatory approach for software products, including mobile medical apps, that will enable efficient oversight of these digital technologies and maintain FDA’s
“gold standard for product review,” Gottlieb said. “We’re advancing a more modern approach for these products that’s carefully adapted to the unique characteristics of these opportunities.”